BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIBLE SILICONE DRILL DRIVER

    MDR report key: 15155696 · Received August 3, 2022

    Report

    Report Number
    0001825034-2022-01764
    Event Type
    Malfunction
    Date Received
    August 3, 2022
    Date of Event
    July 11, 2022
    Report Date
    September 15, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HTW
    UDI-DI
    00880304569126
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, PRODUCT WAS DISCARDED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. H3 OTHER TEXT : DEVICE WAS DISCARDED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED. ONE FLEXIBLE SILICONE DRILL DRIVER (ITEM# 110010733, LOT# 152382) WAS RECEIVED AND EVALUATED AGAINST THE COMPLAINT. PRODUCT WAS IDENTIFIED BY THE ETCH ON THE DRIVER END OF THE DEVICE. VISUAL INSPECTION CONFIRMS THAT THE QUICK CONNECT SLEEVE AND CAP ARE FRACTURED COMPLETELY FROM THE DRIVER. THE QUICK CONNECT SLEEVE AND CAP WERE NOT RETURNED FOR EVALUATION. FRACTURED WIRES FROM THE SHAFT ARE PROTRUDING FROM THE END OF THE BLACK SILICONE OVERMOLD. THE SILICONE OVERMOLD IS TWISTED SLIGHTLY NEAR THE FRACTURED END AND HAS SEVERAL NICKS/ CUTS ALONG THE SURFACE. A REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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 THE FLEXIBLE SILICONE DRILL DRIVER BROKE DURING CASE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION ON THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719489 FLEXIBLE SILICONE DRILL DRIVER PROSTHESIS, HIP HTW ZIMMER BIOMET, INC. N/A 152382 00880304569126

    Patients

    Seq Age Sex Outcome Treatment
    1 Female