Rasp for Bipolar — Small and Large Fenestrated Femoral Broaches

Rasp for Bipolar, SKUs PS-OP-5572 through PS-OP-5575, is a reusable German stainless steel femoral broach for preparing the intramedullary canal before insertion of a compatible bipolar hip prosthesis. The four configurations are Non-Fenestrated Small model PS-OP-5572, Non-Fenestrated Large PS-OP-5573, Fenestrated Small PS-OP-5574, and Fenestrated Large PS-OP-5575. Each instrument combines a stem-matched broach profile with longitudinal cutting teeth and a proximal connection for the corresponding rasp handle or introducer. Fenestrated bodies incorporate openings through the working section to receive displaced cancellous bone and facilitate removal of accumulated debris. Solid versions maintain an uninterrupted body between the cutting surfaces. The instrument is used during bipolar hemiarthroplasty for displaced intracapsular femoral-neck fractures, selected avascular necrosis cases, failed internal fixation, nonunion reconstruction, and system-compatible revision procedures. Orthopedic trauma surgeons and hip arthroplasty specialists use the rasp after femoral-head extraction, neck osteotomy, and canal entry in hospital operating rooms, trauma departments, specialist orthopedic centers, and joint-replacement facilities. The selected profile must correspond with the planned femoral stem and operative system.

Toothed Broach Profile and Fenestrated Body Mechanics

The working section carries longitudinal cutting teeth that engage cancellous bone as the instrument advances along the proximal femoral axis. Each controlled insertion removes material according to the broach envelope, while extraction clears the pathway and permits inspection of depth, orientation, and bone engagement. The small and large bodies create different preparation profiles corresponding with their designated femoral stem sizes. Fenestrated models incorporate openings within the broach body. These spaces receive bone fragments displaced by the surrounding teeth, reduce packing between cutting surfaces, and provide visual access during cleaning. Non-fenestrated versions use a continuous metal body that supports the teeth without internal windows. Neither construction changes the requirement for repeated withdrawal and removal of accumulated osseous material. A proximal coupling connects the instrument to a compatible handle, transferring axial impaction and extraction force along the broach centerline. The surgeon uses that connection to maintain anteversion and coronal alignment. Resistance felt through the handle indicates changing cancellous engagement or cortical proximity. Abrupt eccentric resistance, unstable coupling, unintended varus progression, or advancement beyond the planned depth requires reassessment before further impaction.

Bipolar Hemiarthroplasty Canal Preparation

Use begins after hip exposure, femoral-head removal, and neck resection during bipolar hemiarthroplasty. The proximal femur is elevated and protected, then an opening instrument establishes canal access in line with the femoral shaft. Rasp for Bipolar is attached to its matching handle and introduced at the planned anteversion. Controlled impaction advances the teeth through cancellous bone while the surgeon monitors alignment, rotational position, seating depth, and cortical resistance. The broach is removed periodically so bone fragments can be cleared and the preparation pathway inspected. In surgery for a displaced femoral-neck fracture, the canal is prepared according to the selected bipolar stem rather than the external diameter of the bipolar head. The femoral head gauge and bipolar trials serve separate later functions and do not determine broach geometry. Once the intended preparation is reached, the corresponding trial or definitive stem assessment evaluates axial seating, version, offset, limb length, and hip stability. Fenestrated openings can collect debris during advancement, but they must not be treated as a substitute for canal inspection. The instrument should not be rotated forcibly against the cortex or used to correct an inaccurately positioned entry portal.

Small, Large, Fenestrated, and Solid Selection

Non-Fenestrated Small PS-OP-5572 provides a reduced cutting envelope with a continuous broach body. It is selected for a compatible small bipolar stem after templating and canal assessment. Non-Fenestrated Large PS-OP-5573 prepares the broader profile associated with the corresponding large prosthesis while retaining solid construction. Fenestrated Small PS-OP-5574 combines the reduced body dimensions with debris-receiving openings through the working section. Fenestrated Large PS-OP-5575 provides the broader cutting envelope with the same open-body principle. Small and large options are not arbitrary descriptions of patient stature; they refer to implant-system preparation profiles. Selection considers femoral canal width, metaphyseal morphology, cortical thickness, bone quality, neck resection, planned stem size, and operative technique. Fenestrated versus solid construction affects debris accommodation and cleaning access but does not authorize interchange between unmatched implants. The surgeon should select the profile that reproduces the definitive prosthesis geometry and confirm preparation through the corresponding trial workflow. Hospitals stocking all four configurations should maintain distinct tray positions, visible SKU identification, and instrument-to-implant mapping so the wrong broach is not introduced during fracture surgery.

German Stainless Steel, Cleaning, and Procurement Documentation

German stainless steel provides the corrosion resistance, structural rigidity, and dimensional stability required for a reusable orthopedic broach exposed to repeated impaction and reprocessing. Machined cutting teeth require direct inspection after each procedure because retained bone, rounded edges, bending, chipping, corrosion, or impact deformation can alter the prepared canal. Cleaning should begin before biological material dries across the working surfaces. Fenestrated openings require brushing and visual inspection from both sides, while the solid variants require close attention to the spaces between adjacent flutes. The rasp should be separated from its handle where the validated design permits, then cleaned, rinsed, dried, packaged, and steam sterilized according to the healthcare facility’s approved protocol and manufacturer instructions. CE documentation concerns conformity with applicable European medical-device requirements. ISO 13485 addresses the quality management system governing manufacture and traceability. FDA-related procurement requires the establishment, listing, labeling, importer, and market-access documentation applicable to the destination. Hospitals should maintain variant identification, inspection history, repair records, and sterilization traceability. A broach with damaged teeth, a distorted body, obstructed windows, corrosion, or an unstable coupling must be removed from service.

How does a bipolar rasp differ from a Thompson rasp?
Rasp for Bipolar prepares the femoral canal for a compatible bipolar stem system. A Thompson rasp follows the preparation geometry of a Thompson-pattern monoblock prosthesis. Differences can include proximal contour, stem taper, body width, tooth distribution, and intended seating depth. The bipolar head diameter does not make the two broach patterns interchangeable. An unmatched instrument can create a canal envelope that does not correspond with the definitive stem. Selection must follow the implant system, stem profile, operative technique, and tray documentation.

How are the four rasp configurations selected?
Rasp for Bipolar is supplied in small and large profiles with fenestrated or non-fenestrated bodies. Small versions correspond with the reduced stem preparation envelope within the supported implant system. Large models create the broader canal profile required for their matching prosthesis. Fenestrated options accommodate displaced bone fragments within openings through the broach body. Non-fenestrated instruments use a continuous solid section between the cutting surfaces. Final selection depends on preoperative templating, canal morphology, planned stem size, bone condition, and system compatibility.

What do CE, ISO 13485, and FDA references mean for this product?
CE documentation concerns conformity with applicable European medical-device requirements. ISO 13485 addresses the manufacturer’s medical-device quality management system and traceability controls. Neither reference independently means that Rasp for Bipolar has received FDA approval. United States purchasing requires the relevant establishment, listing, labeling, importer, and market-access documentation. Hospitals should retain these records together with the ordered SKU and variant description. The information supports supplier qualification, inventory control, maintenance, and complaint handling.

How does the handle connection control the rasp?
The proximal coupling joins Rasp for Bipolar to its compatible handle or introducer. A fully seated connection transfers axial impaction and extraction force through the broach centerline. The surgeon uses the handle to control anteversion, coronal alignment, depth, and rotational orientation. Resistance transmitted through the coupling provides tactile information during cancellous bone removal. The connection should be checked before every insertion and after difficult extraction. A loose, worn, distorted, or contaminated coupling must be removed from operative use.

Do fenestrated rasps require a different cleaning workflow?
Fenestrated models require direct access to the openings as well as the external cutting teeth. Rasp for Bipolar should be processed before bone and biological material dry on the working surfaces. Each window must be brushed, flushed, rinsed, and visually inspected from both sides under the validated cleaning procedure. Solid versions also require inspection between every flute and around the proximal connection. After cleaning and drying, the selected instrument should be packaged and sterilized under the facility’s validated protocol. A rasp containing retained debris or displaying damaged cutting surfaces should not be released for surgery.