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: 10165571 · Received June 17, 2020

    Report

    Report Number
    0001032347-2020-00271
    Event Type
    Malfunction
    Date Received
    June 17, 2020
    Date of Event
    May 27, 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
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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 13 POSSIBLE LOTS: 255860, 061220, 394390, 394370, 623130, 623100, 894590, 894520, 894500, 894450, 894250, 714360, 229520. D11 ¿ MEDICAL PRODUCTS: 1.5MM SYSTEM TWIST DRILL WITH J NOTCH 1.1 X 50MM, 9MM STOP, PART# 01-7146, POSSIBLE LOT NUMBERS# 255860, 061220, 394390, 394370, 623130, 623100, 894590, 894520, 894500, 894450, 894250, 714360, 229520; LACTOSORB SYSTEM 1.5MM ADJUSTABLE SELF-DRILLING TAP, PART# 915-1595, LOT# 532852.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE COMPLAINT IS CONFIRMED. THE DEVICE WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION SHOWED IT WAS FRACTURED NEAR THE NECK, AT THE START OF THE FLUTED SECTION. THE CERTS FOR THE TWIST DRILL WERE REVIEWED; NO NON-CONFORMANCES WERE FOUND. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. THIS IS THE ONLY COMPLAINT FOR THIS ITEM# 01-7146, VENDOR LOT# 321008. THE MOST LIKELY UNDERLYING CAUSE OF THE COMPLAINT IS THAT EXCESSIVE FORCE WAS APPLIED, IN EXCESS OF WHAT THE INSTRUMENT WAS DESIGNED TO ENCOUNTER. IT IS POSSIBLE THAT THE INSTRUMENT WAS USED OVER THE 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. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. 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.

    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: 0001032347-2020-00271, 0001032347-2020-00272. MEDICAL PRODUCTS: 1.5MM SYSTEM TWIST DRILL WITH J NOTCH 1.1 X 50MM, 9MM STOP, PART# 01-7146, LOT# NI. LACTOSORB SYSTEM 1.5MM ADJUSTABLE SELF-DRILLING TAP, PART# 915-1595, LOT# NI. THE USER FACILITY IS FOREIGN; THEREFORE, A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. REPORT RESOURCE - (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THE DRILL AND TAP FRACTURED DURING SURGERY. THE PROCEDURE WAS COMPLETED USING AN ALTERNATIVE DRILL AND TAP. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628852 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 H10 NARRATIVE 00841036013189

    Patients

    Seq Age Sex Outcome Treatment
    1 SEE H10 NARRATIVE.| SEE H10 NARRATIVE.