BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TW DRILL 1.1X50MM 9MMSTOP W/NT

    MDR report key: 11338848 · Received February 17, 2021

    Report

    Report Number
    0001032347-2021-00071
    Event Type
    Malfunction
    Date Received
    February 17, 2021
    Date of Event
    January 20, 2021
    Report Date
    June 8, 2021
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HBE
    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. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: B4; B5; D9; G3; G6; H1; H2; H3; H4; H6 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 THAT WERE PREVIOUSLY REPORTED. THEIR CORRESPONDING MANUFACTURING DATES ARE AS FOLLOWS:  255860 (MFG DATE: MAR 7, 2020) 061220 (MFG DATE: FEB 26, 2020)  394390 (MFG DATE: DEC 30, 2019) 394370 (MFG DATE: DEC 30, 2019) 623130 (MFG DATE: OCT 27, 2019) 623100 (MFG DATE: OCT 27, 2019) 894590 (MFG DATE: JUL 15, 2019) 894520 (MFG DATE: JUL 15, 2019) 894500 (MFG DATE: JUL 15, 2019) 894450 (MFG DATE: JUL 15, 2019) 894250 (MFG DATE: JUL 15, 2019) 714360 (MFG DATE: JUN 26, 2019) 229520 (MFG DATE: JUN 3, 2019) VISUAL EXAMINATION OF THE RETURNED PRODUCT CONFIRMED THAT THE DRILL HAD FRACTURED AT THE START OF THE FLUTED SECTION. MEDICAL RECORDS WERE NOT PROVIDED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. THE SUPPLIER DHRS WERE NOT REQUESTED BECAUSE THE RAW MATERIAL CERTIFICATES SHOWED MATERIAL IS CONFORMING TO SPECIFICATION. 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). 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, FOREIGN - EVENT OCCURRED IN (B)(6). 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. 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 THAT APPROXIMATELY FOUR (4) WEEKS AGO DURING SURGERY, THE DRILL TIP BROKE WHILE SURGEON WAS DRILLING PILOT HOLE. THE SURGEON USED A SPARE DRILL TIP TO COMPLETE THE SURGERY AND PATIENT DID NOT EXPERIENCE ANY HARM. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236073 TW DRILL 1.1X50MM 9MMSTOP W/NT INSTRUMENT, MICROFIXATION HBE BIOMET MICROFIXATION NI UNK

    Patients

    Seq Age Sex Outcome Treatment
    1