BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CMK OC - RASP S304

    MDR report key: 22175405 · Received June 10, 2025

    Report

    Report Number
    3006946279-2025-00070
    Event Type
    Malfunction
    Date Received
    June 10, 2025
    Date of Event
    June 2, 2025
    Report Date
    February 4, 2026
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    LZO
    UDI-DI
    03599870033692
    PMA / PMN Number
    EXEMPT
    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 (B)(4). D10: CMK OC - RASP S202; ITEM# 88-100-22000; LOT# 1921365030. CMK OC - RASP S301; ITEM# 88-100-31000; LOT# 1921365050. CMK OC - RASP S401; ITEM# 88-100-41000; LOT# 1921365090. CMK OC - RASP S302; ITEM# 88-100-32000; LOT# 1921365060; QUANTITY- (B)(4). 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 THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, G6, H2, H11. UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THIS PRODUCT AND MEDWATCH REPORT SHOULD NOT HAVE BEEN REPORTED UNDER THIS MFR NUMBER. THIS REPORT SHOULD BE VOIDED AND A CORRECTED REPORT WILL BE FILED UNDER MFR NUMBER (B)(4). 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

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D4, D9, G3, G6, H2, H3, H6, H10, H11. 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 10 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. 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. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. 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. A DEFINITIVE ROOT CAUSE CANNOT 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.

    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.

    Description of Event or Problem · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THIS PRODUCT AND MEDWATCH REPORT SHOULD NOT HAVE BEEN REPORTED UNDER THIS MFR NUMBER. THIS REPORT SHOULD BE VOIDED AND A CORRECTED REPORT WILL BE FILED UNDER MFR NUMBER (B)(4).

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1355494 CMK OC - RASP S304 HIP INSTRUMENT LZO BIOMET FRANCE S.A.R.L. 1921365080 03599870033692

    Patients

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