BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TW DRILL 1.1X50MM 9MMSTOP W/NT

    MDR report key: 12886574 · Received November 29, 2021

    Report

    Report Number
    0001032347-2021-00530
    Event Type
    Malfunction
    Date Received
    November 29, 2021
    Date of Event
    October 29, 2021
    Report Date
    December 9, 2021
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HBE
    PMA / PMN Number
    K062842
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET: (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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 LOT NUMBER 321008 ETCHED ON THIS PRODUCT IS THE SUPPLIER LOT. BASED ON A REVIEW OF INVENTORY TRANSACTIONS, THERE ARE THIRTEEN POSSIBLE LOTS: 061220, 229520, 255860, 394370, 394390, 623100, 623130, 714360, 894250, 894450, 894500, 894520, OR 894590. VISUAL EXAMINATION OF THE RETURNED DRILL CONFIRMED THE PRODUCTS' IDENTITY. THE DRILL SHOWS SIGNS OF ATTEMPTED USE. THE DRILL HAS SCRATCHES ON THE SURFACE AND THE DRILL HAS FRACTURED. THE FRACTURE HAS OCCURRED WHERE THE DRILL BASES MEETS THE FLUTED SECTION OF THE DRILL. THE COMPLAINT IS CONFIRMED. A DETERMINATION CANNOT BE MADE AS TO WHAT CAUSED THE FRACTURE. THE CERT WAS REVIEWED AND NO DEVIATIONS WERE IDENTIFIED. THE SUPPLIER DHR WAS NOT REQUESTED BECAUSE THE RAW MATERIAL CERTIFICATE SHOWED MATERIAL IS CONFORMING TO SPECIFICATION, INCLUDING THE MATERIAL HARDNESS. THE 13 ZIMMER LOT DHR'S WERE NOT REVIEWED AS THE THIS LOT IS FOR LABELING PURPOSES ONLY AND THE COMPLAINT IS NOT PACKAGING OR LABELING RELATED. 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. THIS REPORT IS BEING SUBMITTED TO UPDATE ADDITIONAL INFORMATION IN SECTION B4, B5, D4, D9, G3, G6, H2, H3, H6 AND H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PROCEDURE THE NECK AREA OF THE DRILL BROKE WHILE IT WAS SPINNING. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1781339 TW DRILL 1.1X50MM 9MMSTOP W/NT DRILL HBE BIOMET MICROFIXATION N/A SEE H10 NARRATIVE

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown