BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    90° CONTRA ANGLE DRIVER

    MDR report key: 9263211 · Received October 31, 2019

    Report

    Report Number
    0001032347-2019-00480
    Event Type
    Malfunction
    Date Received
    October 31, 2019
    Date of Event
    September 30, 2019
    Report Date
    January 9, 2020
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HRS
    UDI-DI
    00841036123130
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE COMPLAINT WAS OPENED BECAUSE (B)(6) , SALES REP REPORTS A SCREWDRIVERS WITH DEPOSITS OF TISSUE AND BLOOD POST STERILIZATION. THE FOUR (4) 90 DEG CONTRA ANGLE SCREWDRIVR (PART# 24-1189, LOT# 474720, 129290, 449720, 003000) WERE RETURNED FOR INVESTIGATION. IT WAS REPORTED THAT THE STERILIZATION DEPARTMENT OPENED THE HEAD OF THE SCREWDRIVERS (AFTER CLEANING AND STERILIZATION). ACCORDING TO THE EMPLOYEE THERE WERE DEPOSITS OF TISSUE AND BLOOD PRESENT. PROTEIN TEST WAS PERFORMED AND THE TEST RESULT WAS POSITIVE. BECAUSE THE INSTRUMENTS WERE TESTED BY THE HOSPITAL WITH POSITIVE PROTEIN RESULTS, THE COMPLAINT IS CONSIDERED CONFIRMED. VISUAL EVALUATION SHOWED ALL FOUR OF THE CONTRA ANGLE DRIVERS APPEARED TO BE IN GOOD OVERALL CONDITION. THE DRIVERS WERE DISASSEMBLED FOR FURTHER INSPECTION. THE THREE DRIVERS WITH LOT NUMBERS 474720, 129290, AND 449720 WERE EASILY DISASSEMBLED AND WERE FAIRLY CLEAN INTERNALLY, WHICH WOULD BE CONSISTENT WITH THE REPORT THAT THE DRIVERS WERE CLEANED, DISASSEMBLED, AND TESTED FOR PROTEIN. THE FOURTH DRIVER WITH LOT NUMBER 003000 WAS RETURNED WITH A CONTRA ANGLE BLADE (SP-2379) STUCK INSIDE THE HEAD ASSEMBLY. THIS DRIVER WAS DIFFICULT TO DISASSEMBLE AND HAD LOTS OF DEBRIS INSIDE THE HEAD ASSEMBLY. FOLLOWING THE REPORT THAT PROTEIN WAS DETECTED IN THE HEAD ASSEMBLIES OF THESE DRIVERS, VALIDATION #2019-57 - CONTRA ANGLE (24-1189) END USER CLEANING VALIDATION (INCLUDES US & OUS PARAMETERS) WAS CONDUCTED. THIS CLEANING VALIDATION PROVED THAT FOLLOWING THE IFU'S CLEANING INSTRUCTIONS ELIMINATED ALL POSSIBILITY OF RESIDUAL PROTEINS WITHIN THE INSTRUMENT. THE DHR'S FOR THESE PRODUCTS WERE REVIEWED, NO NON-CONFORMANCES WERE FOUND. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. THIS IS THE ONLY COMPLAINT REGARDING DEPOSITS OF TISSUE AND BLOOD FOR THIS PART# 24-1189, LOT #'S 474720, 129290, 449720, AND 003000. THEREFORE, THE MOST LIKELY UNDERLYING CAUSE OF THE COMPLAINT IS THAT THE USER DID NOT FOLLOW THE CLEANING INSTRUCTIONS DETAILED IN THE IFU. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. THE FOLLOWING FIELDS WERE UPDATED: B4 DATE OF THIS REPORT B5 DESCRIBE EVENT OR PROBLEM B4 LOT NUMBER D10 DEVICE AVAILABILITY G4 DATE RECEIVED BY MANUFACTURER G7 TYPE OF REPORT H2 FOLLOW UP TYPE H3 DEVICE EVALUATED BY MANUFACTURER H4 DEVICE MANUFACTURER DATE H6 METHOD CODE H6 RESULTS CODE H6 CONCLUSIONS CODE H10 ADDITIONAL NARRATIVES/DATA.

    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). THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. IT IS UNKNOWN AT THIS TIME IF THE DEVICE WILL BE RETURNED FOR EVALUATION. THE USER FACILITY IS FOREIGN; THEREFORE A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. REPORT SOURCE: (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED AN INSTRUMENT CONTAINED BLOOD AND TISSUE FOLLOWING THE CLEANING AND STERILIZATION PROCESS. PROTEIN TEST WAS PERFORMED AND THE TEST RESULT WAS POSITIVE. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1053241 90° CONTRA ANGLE DRIVER PLATE, BONE HRS BIOMET MICROFIXATION N/A 474720 00841036123130

    Patients

    Seq Age Sex Outcome Treatment
    1