BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CMK OC - RASP S303

    MDR report key: 24197763 · Received January 28, 2026

    Report

    Report Number
    3002806535-2026-00031
    Event Type
    Malfunction
    Date Received
    January 28, 2026
    Date of Event
    May 14, 2025
    Report Date
    February 9, 2026
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    UDI-DI
    03599870033685
    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 S303; ITEM# 88-100-33000; LOT# 1921365070; QUANTITY- 3. 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. 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. THE PRODUCTS INVOLVED IN THE REPORTED EVENT WERE RETURNED FOR INVESTIGATION. ALL 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 ZIMMER BIOMET (ZB) ETCHING IS APPLIED TO THE HANDLE COMPONENT. AS NO HANDLES WERE RETURNED, NO ZB ETCH CONTENT WAS AVAILABLE FOR VERIFICATION. THE PROXIMAL FACES OF ALL RETURNED RASPS SHOW EVIDENCE OF MODIFICATION, FEATURING CONSISTENT OR SIMILAR GEOMETRIC ALTERATIONS. THESE INCLUDE POSTS EXHIBITING VISUAL CHARACTERISTICS CONSISTENT WITH FRACTURED SURFACES. HOWEVER, NO FRACTURED POST FRAGMENTS WERE RETURNED FOR ANALYSIS. ADDITIONALLY, NON-ZB 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 THAT COULD BE RELATED TO THE REPORTED EVENT. REVIEW OF THE COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED COMPLAINTS FOR THIS ITEM AND THE REPORTED PART AND LOT COMBINATION. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. 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.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO CORRECT THE G3 IN THE PREVIOUS MEDWATCH REPORT (3002806535-2026-00031). CORRECT G3: (B)(6), 2026.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE RASP BROKE DURING INTERNAL TESTING. NO PATIENT INVOLVED, NO HARM TO THE OPERATOR. ATTEMPTS HAVE BEEN MADE, AND ALL ADDITIONAL INFORMATION RECEIVED HAS BEEN INCLUDED IN THIS REPORT. UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THIS PRODUCT WAS EARLIER REPORTED UNDER THE INCORRECT MFR NUMBER (3006946279-2025-00080).

    Description of Event or Problem · 0

    THIS REPORT IS BEING SUBMITTED TO CORRECT THE G3 IN THE PREVIOUS MEDWATCH REPORT (3002806535-2026-00031). CORRECT G3: (B)(6) 2026.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260919 CMK OC - RASP S303 HIP INSTRUMENT LZO BIOMET UK LTD. 1921365070 03599870033685

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE H11 NARRATIVE