BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.5MM SYSTEM TWIST DRILL WITH J NOTCH 1.1 X 50MM, 9MM STOP

    MDR report key: 10368991 · Received August 5, 2020

    Report

    Report Number
    0001032347-2020-00357
    Event Type
    Malfunction
    Date Received
    August 5, 2020
    Date of Event
    July 21, 2020
    Report Date
    October 27, 2020
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HBE
    UDI-DI
    00841036013189
    PMA / PMN Number
    K062842
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE COMPLAINT IS CONFIRMED. THE TW DRILL 1.1X50MM 9MMSTOP W/NT (ITEM# 01-7146, VENDOR LOT# 354700) WAS RETURNED FOR INVESTIGATION. A VISUAL INSPECTION CONFIRMED THE DRILL WAS FRACTURED AT THE START OF THE FLUTED PORTION OF THE DRILL. 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# 01-7146, VENDOR LOT# 354700. THE MOST LIKELY UNDERLYING CAUSE OF THE COMPLAINT IS EXCESSIVE FORCE WAS APPLIED, BEYOND WHAT THE DRILL WAS DESIGNED TO ENCOUNTER. IT IS POSSIBLE THAT THE DRILL WAS USED OVER ITS MAXIMUM RECOMMENDED SPEED, IT WAS USED TO DRILL INTO HIGH DENSITY BONE, EXCESSIVE NORMAL FORCE WAS APPLIED DURING DRILLING, OR OFF-AXIS FORCES WERE APPLIED DURING DRILLING. 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. D4 - THE LOT NUMBER ETCHED ON THE INSTRUMENT IS THE VENDOR'S LOT. A COMPARISON OF INVENTORY TRANSACTIONS TO THE CUSTOMER'S PURCHASE HISTORY FOUND 29 POSSIBLE LOTS: 023990, 061220, 089670, 112640, 203250, 229520, 269720, 332110, 437630, 533540, 541535, 556150, 556150, 556150, 556150, 572481, 572481, 582210, 582210, 591210, 596900, 668320, 691060, 718930, 784820, 797190, 850000, 987520 THE FOLLOWING FIELDS WERE UPDATED: B4 DATE OF THIS REPORT B5 DESCRIBE EVENT OR PROBLEM D4 SERIAL NUMBER, LOT NUMBER D10 DEVICE AVAILABILITY G4 DATE RECEIVED BY MANUFACTURER G7 TYPE OF REPORT H2 FOLLOW UP TYPE H3 DEVICE EVALUATED BY MANUFACTURER H4 DEVICE MANUFACTURER DATE 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.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DRILL BROKE WHEN THE SURGEON WAS PREPARING DRILL HOLES FOR SUTURES IN THE PATIENT'S MIDFACE. IT TOOK TWO (2) MINUTES TO REMOVE THE FRACTURED PIECE OF THE DRILL BIT FROM THE BONE WITH NEEDLE HOLDERS. THE PROCEDURE WAS COMPLETED USING A BACK UP DRILL. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    831554 1.5MM SYSTEM TWIST DRILL WITH J NOTCH 1.1 X 50MM, 9MM STOP DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE BIOMET MICROFIXATION N/A SEE ADDITIONAL INFO 00841036013189

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR