BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.2MMX30MM RNGLC+ ACET DRL BIT

    MDR report key: 12560990 · Received October 1, 2021

    Report

    Report Number
    0001825034-2021-02786
    Event Type
    Malfunction
    Date Received
    October 1, 2021
    Report Date
    May 18, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HTW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: B4, B5, D9, G3, G6, H2, H3, H6, H10 H6: COMPONENT CODE: MECHANICAL (G04) DRILL A 3.2MMX30MM RNGLC+ ACET DRL BIT, PART # 31-323230 FROM LOT 798150, WAS RETURNED AND EVALUATED AGAINST THE COMPLAINT. VISUAL INSPECTION FOUND THE BIT TO BE BENT. NO FLUTE DAMAGE WAS OBSERVED. THE ADDITIONAL INFORMATION DOES NOT CHANGE THE OUTCOME OF THE PREVIOUS INVESTIGATION. 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 · 0

    DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES 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.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN THE PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED A FOLLOW-UP MDR WILL BE SUBMITTED CONCOMITANT PRODUCTS: PART # 31-323215/ ACET DRL BIT/ LOT # 355320. PART # 31-323230 / ACET DRL BIT/ LOT # 232600. PART # 31-323215/ ACET DRL BIT/ LOT # 264520. PART # 31-323220/ ACET DRL BIT/ LOT # 099920. REPORT SOURCE: (B)(6). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS 0001825034 - 2021 - 02785, 0001825034 - 2021 - 02787, 0001825034 - 2021 - 02788, 0001825034 - 2021 - 02789.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DRILL BITS WERE FRACTURED DURING DRILLING. NO ADVERSE CONSEQUENCES WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1457888 3.2MMX30MM RNGLC+ ACET DRL BIT INSTRUMENT, HIP HTW ZIMMER BIOMET, INC. NI 798150

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown SEE H10