BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TW DRILL 1.1X105MM 18MM STP

    MDR report key: 11596730 · Received March 31, 2021

    Report

    Report Number
    0001032347-2021-00162
    Event Type
    Malfunction
    Date Received
    March 31, 2021
    Date of Event
    March 18, 2021
    Report Date
    July 27, 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: MULTIPLE LOTS WERE IDENTIFIED FROM THE VENDOR LOT, IT IS ONE OF THE FOLLOWING: ITEM#: 01-7149, LOT#: 761850 MANUFACTURE DATE: MAY 22, 2020 UDI: (B)(4). ITEM#: 01-7149, LOT#:761860 MANUFACTURE DATE: MAY 22, 2020 UDI: ((B)(4). ITEM#: 01-7149, LOT#: 761870 MANUFACTURE DATE: MAY 22, 2020 UDI: (B)(4). ITEM#: 01-7149, LOT#: 761880 MANUFACTURE DATE: MAY 22, 2020 UDI: (B)(4). ITEM#: 01-7149, LOT#: 761900 MANUFACTURE DATE: MAY 22, 2020 UDI: (B)(4). ITEM#: 01-7149, LOT#: 761910 MANUFACTURE DATE: MAY 22, 2020 UDI: (B)(4). ONE EACH OF ITEM# 01-7149 LOT# 355862, ITEM# 01-7149 LOT# 324428, ITEM# 01-9196 LOT# 324112 WERE RECEIVED AND ITEM/LOT VERIFIED TO COMPLAINT. VISUAL VERIFICATION OF FRACTURE CONFIRMED AS WELL AS BENDING OF ALL THREE DEVICES AT WHAT WOULD APPEAR TO BE THE BREAKING POINTS. ITEM# 01-7149 LOT# 761850, 761860, 761870, 761880, 761900, 761910- REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. 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). CONCOMITANT MEDICAL PRODUCTS: TW DRILL 1.1X105MM 18MM STP CAT# 01-7149 LOT#324428, DRILL 1.5X50MM 22MM STP J-NT CAT# 01-9196 LOT#324112. DISTRIBUTOR ON BEHALF OF FACILITY. REPORT SOURCE 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 - 00163, 0001032347 - 2021 - 00164.

    Description of Event or Problem · 1

    ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496363 TW DRILL 1.1X105MM 18MM STP FLUTED SURGICAL DRILL BIT, REUSABLE HBE BIOMET MICROFIXATION N/A 355862

    Patients

    Seq Age Sex Outcome Treatment
    1