BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.5MM SYSTEM TWIST DRILL WITH J NOTCH 1.1 X 50MM, 15MM STOP

    MDR report key: 10253390 · Received July 9, 2020

    Report

    Report Number
    0001032347-2020-00304
    Event Type
    Malfunction
    Date Received
    July 9, 2020
    Date of Event
    June 29, 2020
    Report Date
    August 25, 2020
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HBE
    UDI-DI
    00841036013196
    PMA / PMN Number
    K062842
    Removal / Correction Number
    N/A
    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. THE FOLLOWING FIELDS WERE UPDATED: B4 DATE OF THIS REPORT. B5 DESCRIBE EVENT OR PROBLEM. D4 LOT NUMBER - BASED ON A REVIEW OF INVENTORY TRANSACTIONS AND THIS CUSTOMER'S PURCHASE HISTORY, THERE ARE FOUR (4) POSSIBLE LOTS: 714300 894080 893950 893900.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE COMPLAINT IS CONFIRMED. THE DRILL WAS RETURNED FOR EVALUATION. ON VISUAL INSPECTION, THE DRILL WAS NOTED TO HAVE A TRANSVERSE FRACTURE THROUGH THE FLUTES NEAR THE NECK. THE CERTIFICATE OF CONFORMANCE WAS REVIEWED AND THERE WERE NO NON-CONFORMANCES WERE FOUND. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. THIS IS THE ONLY COMPLAINT IN REGARDS TO THE DRILL FRACTURING FOR 01-7148 LOT 335380. FOR THIS PART (01-7148) AND THE PREVIOUS ONE YEAR (FROM THE NOTIFICATION DATE) REGARDING THE DRILL FRACTURING, (B)(4). THE MOST LIKELY UNDERLYING CAUSE OF THE COMPLAINT IS THE DRILL EXPERIENCED FORCE IN EXCESS OF WHAT IT WAS DESIGNED TO ENCOUNTER; FRACTURES AT THIS POINT OF THE DRILL ARE TYPICAL OF EXCESSIVE FORCE FRACTURES. 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. THE FOLLOWING FIELDS WERE UPDATED: B4 DATE OF THIS REPORT B5 DESCRIBE EVENT OR PROBLEM D10 DEVICE AVAILABILITY G4 DATE RECEIVED BY MANUFACTURER G7 TYPE OF REPORT H2 FOLLOW UP TYPE H3 DEVICE EVALUATED BY MANUFACTURER H6 METHOD CODE H6 RESULTS CODE H6 CONCLUSIONS CODE H10 ADDITIONAL NARRATIVES/DATA

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (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. THE USER FACILITY IS FOREIGN; THEREFORE, A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THE DRILL BIT FRACTURED DURING A RECONSTRUCTION SURGERY. THE PROCEDURE WAS COMPLETED WITH ANOTHER DRILL BIT. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718339 1.5MM SYSTEM TWIST DRILL WITH J NOTCH 1.1 X 50MM, 15MM STOP DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE BIOMET MICROFIXATION N/A SEE H10 NARRATIVE 00841036013196

    Patients

    Seq Age Sex Outcome Treatment
    1