BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTRA DRILL 1.5X15.5MM STP

    MDR report key: 12083938 · Received June 29, 2021

    Report

    Report Number
    0001032347-2021-00355
    Event Type
    Malfunction
    Date Received
    June 29, 2021
    Date of Event
    November 5, 2020
    Report Date
    July 7, 2021
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HBE
    UDI-DI
    00841036016890
    PMA / PMN Number
    K062842
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. TWO OF ITEM 01-9181 CONTRA DRILL 1.5X15.5MM STP WERE RETURNED. VISUAL EVALUATION OF THE DRILLS SHOWS THAT THE BITS FRACTURED IN THE FLUTED SECTION OF THE DRILL BITS. NO OTHER ANOMALIES COULD BE IDENTIFIED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION 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

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

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347-2020-00583. LOT NUMBER GIVEN BY REPORTER WAS THE VENDOR LOT NUMBER. THERE ARE 5 POSSIBLE END-LEVEL LOT NUMBERS FOR THIS DEVICE: LOT# M054140, LOT# M101640, LOT# M049140, LOT# M659010, LOT# M896130. LOT# M054140; DEVICE MANUFACTURER DATE: 2020-07-16, LOT# M101640; DEVICE MANUFACTURER DATE: 2019-12-05, LOT# M049140; DEVICE MANUFACTURER DATE: 2019-11-27, LOT# M659010; DEVICE MANUFACTURER DATE: 2019-11-10, LOT# M896130; DEVICE MANUFACTURER DATE: 2019-07-17. CONCOMITANT MEDICAL PRODUCTS: ITEM# 01-9181; LOT# 133310. FULL ESTABLISHMENT NAME: (B)(6) UNIVERSITY. FOREIGN: EVENT OCCURRED IN (B)(6). 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. 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 · 1

    IT WAS REPORTED APPROXIMATELY SEVEN (7) MONTHS AGO, THE DRILL FRACTURED NEAR THE NECK OF THE DRILL TIP WHILE DRILLING THE MANDIBLE. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DRILL BIT. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    978704 CONTRA DRILL 1.5X15.5MM STP INSTRUMENT, MICROFIXATION HBE BIOMET MICROFIXATION NI SEE NARRATIVE IN H10 00841036016890

    Patients

    Seq Age Sex Outcome Treatment
    1