BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL 1.5X105MM 22MM STP J-NT

    MDR report key: 11737109 · Received April 28, 2021

    Report

    Report Number
    0001032347-2021-00237
    Event Type
    Malfunction
    Date Received
    April 28, 2021
    Date of Event
    April 7, 2021
    Report Date
    July 22, 2021
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HBE
    PMA / PMN Number
    K062842
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D4: 5 POTENTIAL LOTS WERE RECOGNIZED FROM THE VENDOR LOT FOR THIS DEVICE. IT IS ONE OF THE FOLLOWING: ITEM#: (B)(6), LOT#: 008280. MANUFACTURE DATE: JUL 17, 2019. UDI: (B)(4). 510K: K062842, FDA PROD CODE: HBE. ITEM#: (B)(6), LOT#: 008390. MANUFACTURE DATE: JUL 17, 2019. UDI: (B)(4). 510K: K062842, FDA PROD CODE: HBE. ITEM#: (B)(6), LOT#: 008420. MANUFACTURE DATE: JUL 17, 2019. UDI: (B)(4). 510K: K062842, FDA PROD CODE: HBE. ITEM#: (B)(6), LOT#: 008430. MANUFACTURE DATE: JUL 17, 2019. UDI: (B)(4). 510K: K062842, FDA PROD CODE: HBE. ITEM#: (B)(6), LOT#: 008450. MANUFACTURE DATE: JUL 17, 2019. UDI: (B)(4). 510K: K062842, FDA PROD CODE: HBE. THE DRILL 1.5X105MM 22MM STP J-NT (ITEM# (B)(6), LOT# 333925) WERE RETURNED FOR INVESTIGATION. IT WAS DETERMINED THAT THE '333925' ETCHED ON THE BODY OF THIS DRILL IS THE VENDOR'S LOT. BASED ON A REVIEW OF INVENTORY TRANSACTIONS AND THE CUSTOMER'S PURCHASE HISTORY, THERE ARE 5 POSSIBLE ZIMMER BIOMET LOTS: 008280, 008390, 008420, 008430, OR 008450. VISUAL EXAMINATION OF THE RETURNED DRILL CONFIRMED THE PRODUCT'S IDENTITY. IT WAS ALSO CONFIRMED THAT THE 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.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). OCCUPATION: DISTRIBUTOR ON BEHALF OF FACILITY MFR SITE: (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 THAT DURING AN INITIAL SEGMENT PROCEDURE, A DRILL TIP WAS BROKEN DURING DRILLING WHEN FIXING THE SCREW. 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
    634019 DRILL 1.5X105MM 22MM STP J-NT DRILLS, BURRS, TREPHINES & ACCESSORIES HBE BIOMET MICROFIXATION N/A 333925

    Patients

    Seq Age Sex Outcome Treatment
    1