BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    90° CONTRA ANGLE DRIVER

    MDR report key: 7657356 · Received July 2, 2018

    Report

    Report Number
    0001032347-2018-00426
    Event Type
    Malfunction
    Date Received
    July 2, 2018
    Date of Event
    June 5, 2018
    Report Date
    December 14, 2018
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HRS
    PMA / PMN Number
    PK142823
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. THE 90 DEGREE CONTRA ANGLE SCREWDRIVER (PART# 24-1189, LOT# 490190) AND CONTRA ANGLE TEMPORARY FIXATION SCREW (PART# 76-0017, LOT# 632390) WERE RETURNED IN A RED BIOHAZARD BAG. VISUAL INSPECTION SHOWED THAT THE SCREWDRIVER WAS DISCOLORED. THE TEMPORARY FIX SCREW WAS SIGNIFICANTLY BENT AND COULD NOT BE RELEASED FROM THE SCREWDRIVER COLLET. THE SCREWDRIVER WAS NOT DISASSEMBLED DUE TO THE FACT THAT IT WAS RETURNED IN A BIOHAZARDOUS CONDITION. FURTHER FUNCTIONAL TESTS AND INSPECTIONS COULD NOT BE PERFORMED DUE TO THE BIO HAZARDOUS STATE OF THE PRODUCT. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT WAS DUE TO WAS DUE TO THE SUPPLIER USING BLADES, AND NOT THE MIN/MAX GAGE, TO DESIGN THE COLLET RESULTING IN THE COLLET FAILING THE MAX GAGE INSPECTION. 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 REPORT: 0001032347-2018-00427-1.

    Description of Event or Problem · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). MEDICAL PRODUCT: BIOMET MICROFIXATION RIBFIX BLU SYSTEM TEMPORARY FIXATION SCREW, CONTRA ANGLE CATALOG #: 76-0017, LOT #: 632390. THERAPY DATE: (B)(6) 2018. PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001032347-2018-00427.

    Description of Event or Problem · 1

    IT WAS REPORTED A TEMPORARY FIXATION PIN WAS STUCK IN THE CONTRA ANGLE DRIVER. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING ANOTHER 90° CONTRA ANGLE DRIVER. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496402 90° CONTRA ANGLE DRIVER SCREWDRIVER HRS BIOMET MICROFIXATION N/A 490190

    Patients

    Seq Age Sex Outcome Treatment
    1