BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CMK OC - RASP S302

    MDR report key: 24267080 · Received February 5, 2026

    Report

    Report Number
    3002806535-2026-00063
    Event Type
    Malfunction
    Date Received
    February 5, 2026
    Date of Event
    June 2, 2025
    Report Date
    February 5, 2026
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    UDI-DI
    03599870033678
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D4: THIS DEVICE IS SOLD OUTSIDE THE US AND THEREFORE NO GUDID INFORMATION EXISTS. THIS DEVICE IS CONSIDERED SIMILAR TO 00889024132023. D10: CMK OC - RASP S202; ITEM#: 88-100-22000; LOT#: 1921365030. CMK OC - RASP S301; ITEM#: 88-100-31000; LOT#: 1921365050. CMK OC - RASP S304, ITEM#: 88-100-34000; LOT#: 1921365080. CMK OC - RASP S401; ITEM#: 88-100-41000; LOT#: 1921365090. CMK OC - RASP S302; ITEM#: 88-100-32000; LOT#: 1921365060; QUANTITY- 5. G2: FOREIGN ¿ JAPAN. G4: THE REPORTED PRODUCT IS NOT SOLD IN THE US, THE PRE-MARKET SUBMISSION NUMBER FOR THE SIMILAR PRODUCT SOLD IN THE US IS K192660. COMPLAINT CAN BE CONFIRMED THROUGH THE RETURNED PRODUCT ANALYSIS. THESE INCLUDE POSTS EXHIBITING VISUAL CHARACTERISTICS CONSISTENT WITH FRACTURED SURFACES. THE PRODUCTS INVOLVED IN THE REPORTED EVENT WERE RETURNED FOR INVESTIGATION. ALL TEN RASPS WERE RECEIVED WITHOUT THE HANDLE COMPONENTS, WHICH ARE TYPICALLY WELDED ONTO THE PROXIMAL FACE OF EACH RASP. NO HANDLE COMPONENTS WERE RETURNED FOR EVALUATION. PER DESIGN SPECIFICATIONS, ALL ETCHING IS APPLIED TO THE HANDLE COMPONENT. AS NO HANDLES WERE RETURNED, NO ETCH CONTENT WAS AVAILABLE FOR VERIFICATION. THE PROXIMAL FACES OF ALL RETURNED RASPS SHOW EVIDENCE OF MODIFICATION, FEATURING CONSISTENT OR SIMILAR GEOMETRIC ALTERATIONS. ADDITIONALLY, NON-ZIMMER BIOMET ETCH CONTENT WAS OBSERVED WITHIN THE MODIFIED REGION OF THE PROXIMAL END ON ALL RETURNED RASPS. BASED ON VISUAL INSPECTION, THE RETURNED RASPS DO NOT CONFORM DUE TO THE ALTERED PROXIMAL ENDS. DIMENSIONAL VERIFICATION WAS NOT PERFORMED BECAUSE THE DEVICES ARE IN A MODIFIED STATE. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS. IFU 70964001 HAS BEEN REVIEWED AND STATED: DO NOT POLISH OR MODIFY. REVIEW OF THE COMPLAINT HISTORIES IDENTIFIED ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED ITEMS AND NO ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED PART AND LOT COMBINATIONS. BASED ON THE TECHNICAL EVALUATION, IT CAN BE CONCLUDED THAT THE PRODUCTS HAVE BEEN REPROCESSED AND MODIFIED. IT IS LIKELY THAT THE MODIFICATION CONTRIBUTED TO THE FRACTURE. HOWEVER, IF AND TO WHAT EXTEND OTHER FACTORS MAY HAVE PLAYED A ROLE REMAINS UNKNOWN. THEREFORE, THE ROOT CAUSE OF THE REPORTED ISSUE REMAINS UNKNOWN. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE RASP BROKE DURING INTERNAL TESTING. NO PATIENT WAS INVOLVED, NO HARM TO THE OPERATOR. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER ADDITIONAL INFORMATION HAS BEEN PROVIDED AT THE TIME OF THIS REPORT. UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THIS PRODUCT WAS EARLIER REPORTED UNDER THE INCORRECT MFR NUMBER: (3006946279-2025-00073).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440038 CMK OC - RASP S302 HIP INSTRUMENT LZO BIOMET UK LTD. 1921365060 03599870033678

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE H11 NARRATIVE.