BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIBLE SILICONE DRILL DRIVER

    MDR report key: 7331562 · Received March 12, 2018

    Report

    Report Number
    0001825034-2018-01558
    Event Type
    Malfunction
    Date Received
    March 12, 2018
    Date of Event
    February 1, 2018
    Report Date
    August 6, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HTW
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL INSPECTION CONFIRMED DAMAGE TO THE SILICONE SLEEVE OF EACH DRIVER. THE SILICONE SLEEVE HAS PULLED AWAY FROM QUICK CONNECT END EXPOSING THE FLEXIBLE SHAFT OF EACH DRIVER. THE DAMAGE TO THE SILICONE OF ONE OF THE DRIVERS IS LIMITED TO A SMALL SLIT ON ONE SIDE OF THE DRIVER. THE 2ND DRIVER EXHIBITS A CUT IN THE SILICONE THAT WRAPS AROUND THE DRIVER 4 TIMES. THE SILICONE WAS REMOVED FROM THE CHUCK END OF ONE OF THE DRIVERS. THE EXPOSED SHAFT SHOWS A UNIFORM COIL CONFIRMING THE FRACTURE OF THE INNER WIRES ON THE QUICK CONNECT END. MULTIPLE WIRES IN THE OUTER COIL OF EACH DRIVER HAVE FRACTURED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT: 110010733, FLEXIBLE SILICONE DRILL DRIVER, B151432. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 01559.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSTRUMENT WAS FOUND BROKEN. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173478 FLEXIBLE SILICONE DRILL DRIVER BIT, DRILL HTW ZIMMER BIOMET, INC. N/A B151432

    Patients

    Seq Age Sex Outcome Treatment
    1