BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIBLE SILICONE DRILL DRIVER

    MDR report key: 16554272 · Received March 16, 2023

    Report

    Report Number
    0001825034-2023-00564
    Event Type
    Malfunction
    Date Received
    March 16, 2023
    Date of Event
    February 8, 2023
    Report Date
    March 15, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HTW
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CAT#: 110010245 LOT#: 65273478 G7 OSSEOTI 4 HOLE SHELL 54MM F CAT#: 00-6250-065-30, LOT#: 65299318 BONE SCREW 6.5X30 SELFTAP, CAT#: 00-6250-065-25, LOT#: 64945779 BONE SCREW 6.5X25 SELFTAP, CAT#: 00-6250-065-20, LOT#: 65537987 BONE SCREW 6.5X20 SELFTAP, CAT#: 30103606, LOT#: 65574776 G7 VIT E NEUTRAL LNR 36MM F, CAT#: 00-8775-036-04, LOT#: 3090747 BIOLOX DELTA FEM HEAD, 36MM, +7MM, CAT#: 00-7711-012-20, LOT#: 64918451 M/L TAPER 12.5 EXT, CAT#: 31-323220, LOT#: 991640 3.2MMX20MM RNGLC+ ACET DRL BIT. VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED THE FLEX DRIVER TIP IS CREASED/BENT. LOT IDENTIFICATION IS NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, LOT IDENTIFICATION WAS NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. 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 THE FLEXIBLE DRILL SHAFT BENT WHILE DRILLING A SCREW INTO THE HOLE IN THE G7 ACETABULAR SHELL. ANOTHER TRAY WAS OPENED, AND A NEW FLEXIBLE DRILL BIT WAS USED TO CREATE THE HOLE FOR THE BONE SCREW PLACEMENT. THERE WAS NO KNOWN IMPACT OR CONSEQUENCES TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496530 FLEXIBLE SILICONE DRILL DRIVER INSTRUMENT, HIP HTW ZIMMER BIOMET, INC. N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Male