BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.0X 7MM DIR-DRV LACT SCW 2PK

    MDR report key: 11440706 · Received March 8, 2021

    Report

    Report Number
    0001032347-2021-00109
    Event Type
    Malfunction
    Date Received
    March 8, 2021
    Date of Event
    February 12, 2021
    Report Date
    April 22, 2021
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HWC
    UDI-DI
    00841036125479
    PMA / PMN Number
    K011139
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    6 SCREWS WERE RETURNED FOR EVALUATION. A QUANTITY OF 2 SCREWS FOR 915-2201 LOT 893730 WERE RETURNED. THOSE SCREWS ARE NOT FRACTURED. ALL 6 SCREW THREADS WERE VISUALLY INSPECTED AND NONE OF THE THREADS ARE DAMAGED. NO MEASUREMENTS WERE TAKEN ON THE PRODUCT AS ALL HAVE BEEN USED WITH THE DRIVER AT SOME POINT AFTER LEAVING ZIMMER BIOMET CONTROL. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED DUE TO THE INABILITY TO MEASURE THE DIMENSIONS THE PRODUCT DUE TO ATTEMPTED USE. 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). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347-2021-00110, 0001032347-2021-00111, 0001032347-2021-00112, 0001032347-2021-00113, 0001032347-2021-00114. ITEM# 915-2201; LOT# 893730, ITEM# 915-2200; LOT# 862630, ITEM# 915-2200; LOT# 862630, ITEM# 915-2200; LOT# 862630, ITEM# 915-2200; LOT# 862630 ITEM# UNK SCREWDRIVER. 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 APPROXIMATELY THREE (3) WEEKS AGO, THAT THE SURGEON TRIED TO GRIP THE SCREW WITH A SCREWDRIVER AND THE FIT WAS TOO TIGHT. AS A RESULT, THE SCREW HEAD BROKE. THE SURGEON OPENED A NEW SCREW TO COMPLETE THE SURGERY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330542 2.0X 7MM DIR-DRV LACT SCW 2PK PROSTHESIS, MICROFIXATION HWC BIOMET MICROFIXATION NI 893730 00841036125479

    Patients

    Seq Age Sex Outcome Treatment
    1 SEE NARRATIVE IN H10