BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.0MM SYSTEM TWIST DRILL CONTRA 1.5MM X 30.5MM W/ 15.5MM STOP

    MDR report key: 10209395 · Received June 29, 2020

    Report

    Report Number
    0001032347-2020-00285
    Event Type
    Injury
    Date Received
    June 29, 2020
    Date of Event
    June 18, 2020
    Report Date
    October 28, 2020
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HBE
    UDI-DI
    00841036016890
    PMA / PMN Number
    K062842
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE LOT NUMBER ETCHED ON THE PRODUCT IS THE VENDOR'S LOT. A REVIEW OF THE CUSTOMER'S PURCHASE HISTORY AND INVENTORY TRANSACTIONS FOUND FIVE (5) POSSIBLE LOTS: 900730, 419830, 230080, 089900, 490310 THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE COMPLAINT IS CONFIRMED. THE DEVICE WAS RETURNED FOR INVESTIGATION. THE CONTRA DRILL WAS FOUND TO BE MISSING THE BLUE PAINT IN THE MACHINED GROOVE BETWEEN THE IDENTIFICATION ETCHINGS AND THE FLUTED SECTION. THE CERT WAS REVIEWED AND THERE WERE NO NON-CONFORMANCES FOUND. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. THIS IS THE ONLY COMPLAINT FOR THIS ITEM# 01-9181, VENDOR LOT# 186575. THE MOST LIKELY UNDERLYING CAUSE OF THE CONTRA DRILL'S PAINT PEELING COULD NOT BE DETERMINED. IT IS POSSIBLE THAT THE PAINT PEELED OFF AS A RESULT OF IMPROPER CLEANING AND STERILIZATION OR BEING REUSED. 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347-2020-00284, 0001032347-2020-00285. MEDICAL PRODUCTS: 2.0MM SYSTEM TWIST DRILL WITH J NOTCH 1.5MM X 105MM W/ 22MM STOP, PART# 01-9198, LOT# NI. 2.0MM SYSTEM TWIST DRILL CONTRA 1.5MM X 30.5MM W/ 15.5MM STOP, PART# 01-9181, LOT# NI. THE USER FACILITY IS FOREIGN; THEREFORE, A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. REPORT SOURCE - (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THE DRILL BIT FRACTURED WHILE FIXING THE PLATE WITH A TROCAR. THE DRILL GUIDE WAS UTILIZED. WHEN USING THE CONTRA DRILL BIT, THE PAINT PEELED OFF. PAINT WAS REMOVED FROM THE PATIENT WITH GAUZE, BUT SOME OF THE PAINT MAY REMAIN IN THE PATIENT¿S BODY. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672674 2.0MM SYSTEM TWIST DRILL CONTRA 1.5MM X 30.5MM W/ 15.5MM STOP DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE BIOMET MICROFIXATION N/A SEE H10 NARRATIVE 00841036016890

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SEE H10 NARRATIVE