BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TW DRILL 1.1X50MM 9MMSTOP W/NT

    MDR report key: 11776296 · Received May 5, 2021

    Report

    Report Number
    0001032347-2021-00207
    Event Type
    Malfunction
    Date Received
    May 5, 2021
    Date of Event
    April 6, 2021
    Report Date
    June 23, 2021
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HBE
    PMA / PMN Number
    K062842
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    D4 - THE TWO (2) TW DRILL 1.1X50MM 9MMSTOP W/NT (ITEM# 01-7146, LOT# 321008) WERE RETURNED FOR INVESTIGATION. IT WAS DETERMINED THAT THE '321008' ETCHED ON THE BODY OF THESE DRILLS IS THE VENDOR'S LOT. BASED ON A REVIEW OF INVENTORY TRANSACTIONS AND THE CUSTOMER'S PURCHASE HISTORY, THERE ARE 13 POSSIBLE ZIMMER BIOMET LOTS: 061220, 229520, 255860, 394370, 394390, 623100, 623130, 714360, 894250, 894450, 894500, 894520, OR 894590. IT IS UNKNOWN WHICH EXACT DEVICE ENCOUNTERED THIS ISSUE, IT IS ONE OF THE FOLLOWING: ITEM#: 01-7146, LOT#: 229520, MANUFACTURE DATE: JUN 03, 2019, UDI: (B)(4); ITEM#: 01-7146, LOT#: 255860, MANUFACTURE DATE: MAR 07, 2020, UDI: (B)(4); ITEM#: 01-7146, LOT#: 394370, MANUFACTURE DATE: DEC 30, 2019, UDI: (B)(4); ITEM#: 01-7146, LOT#: 394390, MANUFACTURE DATE: DEC 30, 2019, UDI: (B)(4); ITEM#: 01-7146, LOT#: 623100, MANUFACTURE DATE: OCT 27, 2019, UDI: (B)(4); ITEM#: 01-7146, LOT#: 623130, MANUFACTURE DATE: OCT 27, 2019, UDI: (B)(4); ITEM#: 01-7146, LOT#: 714360, MANUFACTURE DATE: JUN 26, 2019, UDI: (B)(4); ITEM#: 01-7146, LOT#: 894250, MANUFACTURE DATE: JUL 15, 2019, UDI: (B)(4); ITEM#: 01-7146, LOT#: 894450, MANUFACTURE DATE: JUL 15, 2019, UDI: (B)(4); ITEM#: 01-7146, LOT#: 894500, MANUFACTURE DATE: JUL 15, 2019, UDI: (B)(4); ITEM#: 01-7146, LOT#: 894520, MANUFACTURE DATE: JUL 15, 2019, UDI: (B)(4); ITEM#: 01-7146, LOT#: 894590, MANUFACTURE DATE: JUL 15, 2019, UDI: (B)(4). VISUAL EXAMINATION OF THE RETURNED DRILLS CONFIRMED THE PRODUCTS' IDENTITY. IT WAS ALSO CONFIRMED THAT EACH DRILL WAS FRACTURED, NEAR THE NECK AT THE START OF THE FLUTED SECTION. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. THE SUPPLIER DHR WAS NOT REQUESTED BECAUSE THE RAW MATERIAL CERTIFICATE SHOWED MATERIAL IS CONFORMING TO SPECIFICATION, INCLUDING THE MATERIAL HARDNESS. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347-2021-00208.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). TW DRILL 1.1X50MM 9MMSTOP W/NT CAT#01-7146 LOT#321008 FOREIGN: (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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347-2021-00208.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL SEGMENT PROCEDURE IN WHICH DRILL FRACTURED IN THE BONE BECAUSE THE BONE WAS STIFF WHEN THE SURGEON DRILLED A PILOT HOLE. THERE WERE NO DRILL TIPS LEFT IN THE PATIENT'S BODY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673766 TW DRILL 1.1X50MM 9MMSTOP W/NT FLUTED SURGICAL DRILL BIT, REUSABLE HBE BIOMET MICROFIXATION N/A 061220

    Patients

    Seq Age Sex Outcome Treatment
    1 SEE H10