BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIBLE SILICONE DRILL DRIVER

    MDR report key: 15464663 · Received September 22, 2022

    Report

    Report Number
    0001825034-2022-02177
    Event Type
    Malfunction
    Date Received
    September 22, 2022
    Date of Event
    August 29, 2022
    Report Date
    November 1, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HTW
    UDI-DI
    00887868466014
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CAT #:31-323230 ACET DRL BT. LOT #:890740. PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: D4; G3; H2; H3; H4; H6 ONE FLEXIBLE SILICONE DRILL DRIVER ITEM# 110010733 LOT# 196352 WAS RETURNED AND EVALUATED. UPON VISUAL INSPECTION THE BLACK SHEATH OF THE FLEX DRIVER HAD TEARS AND THE SPRING NEAR THE HEAD WAS BENT. 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 DURING A PROCEDURE, WHILE BEGINNING TO DRILL A SCREW INTO A SHELL, THE TOP OF THE DRILL BIT WAS TORQUED AND THE FLEXIBLE DRILL DRIVER WAS BROKEN. THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION ON THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2624891 FLEXIBLE SILICONE DRILL DRIVER INSTRUMENT, HIP HTW ZIMMER BIOMET, INC. NI 196352 00887868466014

    Patients

    Seq Age Sex Outcome Treatment
    1 Female