BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIBLE SILICONE DRILL DRIVER

    MDR report key: 17271328 · Received July 6, 2023

    Report

    Report Number
    0001825034-2023-01521
    Event Type
    Malfunction
    Date Received
    July 6, 2023
    Date of Event
    June 15, 2023
    Report Date
    October 22, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HTW
    UDI-DI
    00887868466014
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 31-323220 3.2MMX20MM RNGLC+ ACET DRL BIT 66040925; 010000660 G7 PPS LTD ACET SHELL 46B 7152794; 00-6250-065-25 BONE SCREW 6.5X25 SELFTAP 65885364; 30103202 G7 VIT E NEUTRAL LNR 32MM B 65574688; 51-103100 TPRLC 133 T1 PPS SO 10X140MM 7121925; 650-1056 CER BIOLOXD OPTION HD 32MM 3133103; 650-1064 CER OPTION TYPE 1 TPR SLEVE -6 3130571. 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 AND/OR CORRECTED INFORMATION. A FLEXIBLE SILICONE DRILL DRIVER, PART # 110010733 FROM LOT 196352, WAS RETURNED AND EVALUATED AGAINST THE COMPLAINT. THE LOT ON THE DRIVER MATCHES THE COMPLAINT. VISUAL INSPECTION OBSERVED THAT THE SILICONE SLEEVE HAS PULLED AWAY FROM THE HEAD OF THE DRIVER EXPOSING THE WIRE SHAFT. ONE OF THE INTERNAL WIRES IS DEFORMED AND UNUNIFORM. SCUFFING IS PRESENT ON THE CONNECTOR. A REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. MEDICAL RECORDS WERE NOT PROVIDED. EVENT CONFIRMED VIA RETURNED PRODUCT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THE RUBBER IS COMING OFF THE FLEXIBLE SILICONE DRILL DRIVER. THERE WAS NO PATIENT INVOLVEMENT REPORTED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE, HOWEVER, NO MORE IS AVAILABLE.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2056706 FLEXIBLE SILICONE DRILL DRIVER HIPS, INSTRUMENTS HTW ZIMMER BIOMET, INC. N/A 196352 00887868466014

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown SEE H10 NARRATIVE