BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G7 POSITIONING GUIDE ROD

    MDR report key: 21314093 · Received February 5, 2025

    Report

    Report Number
    0001825034-2025-00263
    Event Type
    Malfunction
    Date Received
    February 5, 2025
    Date of Event
    January 13, 2025
    Report Date
    June 12, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: 110003457 ITEM NAME RATCHETING SCREWDRIVER HANDLE LOT # 108229; 00-8790-007-05 ITEM NAME FLEXIBLE SHAFT, TRI-SHANK LOT UNKNOWN. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT¿S LOCATION IS NOT KNOWN; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4;G3;H2;H3;H6. RATCHETING SCREWDRIVER HANDLE WAS RETURNED AND EVALUATED. VISUAL REVIEW OF THE RETURNED RATCHETING SCREWDRIVER HANDLE IDENTIFIED SCRATCHES FROM PREVIOUS USES. NO OTHER DAMAGE WAS NOTED. FUNCTIONAL TESTING WAS PERFORMED AND THE GAGE FULLY SEATED INTO THE RATCHET END; HOWEVER, FAILED TO ROTATE IN EITHER THE FORWARD OR REVERSE DIRECTION. THE DEVICE CAN SWITCH THE SETTINGS BETWEEN FORWARD, LOCK, AND REVERSE SMOOTHLY, BUT WOULDN'T RATCHET. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. THE GUIDE ROD WAS NOT RETURNED, AND NO PICTURES WERE PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. LOT IDENTIFICATION IS NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS; LOT IDENTIFICATION WAS NOT PROVIDED. REPORTED EVENT IS NOT RELATED TO A COMBINATION OF PRODUCTS; THEREFORE, A COMPATIBILITY REVIEW IS NOT APPLICABLE. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE COMPLAINT IS CONFIRMED BASED ON THE RETURNED PRODUCT EVALUATION OF THE RATCHETING SCREWDRIVER HANDLE. FRACTURED GUIDE ROD COULD NOT BE CONFIRMED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 PIECES FRACTURED DURING SURGERY FROM WEAR. RATCHETING SCREWDRIVER HANDLE WOULD NOT RATCHET. THE SURGEON NOTED, THE PATIENT HAD HARD BONE WHICH MAY HAVE CONTRIBUTED TO THE DRILL FRACTURING. THE SURGERY WAS COMPLETED USING A BACKUP TRAY. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1061223 G7 POSITIONING GUIDE ROD INSTRUMENT, HIP LXH ZIMMER BIOMET, INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Male