BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.0MM DRILL BIT MINI-QUICK CON

    MDR report key: 10905790 · Received November 25, 2020

    Report

    Report Number
    0001825034-2020-04044
    Event Type
    Malfunction
    Date Received
    November 25, 2020
    Report Date
    March 25, 2021
    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
    SP
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: D4: LOT# IS 039662 AND NOT 39662. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL EXAMINATION OF THE RETURNED PRODUCTS IDENTIFIED THE DEVICES WERE FRACTURED AND MISSING THE FLUTES. DEVICE HISTORY RECORD 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). CONCOMITANT MEDICAL PRODUCTS: ITEM# 231220200; LOT# 140892; 1.0MM DRILL BIT MINIQUICK CON. FOREIGN REPORT SOURCE: (B)(6). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING THE INSPECTION OF THE KIT IN THE (B)(6) WAREHOUSE, IT HAS BEEN DETECTED THAT THE PIECE IS BROKEN. NOT PATIENT INVOLVED. NO SURGERY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1367763 1.0MM DRILL BIT MINI-QUICK CON TRAUMA, INSTRUMENT HTW ZIMMER BIOMET, INC. N/A 039662

    Patients

    Seq Age Sex Outcome Treatment
    1 SEE H10 NARRATIVE