BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    90° CONTRA ANGLE DRIVER

    MDR report key: 7761337 · Received August 8, 2018

    Report

    Report Number
    0001032347-2018-00490
    Event Type
    Malfunction
    Date Received
    August 8, 2018
    Date of Event
    June 27, 2018
    Report Date
    December 17, 2018
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HRS
    PMA / PMN Number
    PK142823
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. THE TWO (2) 90 DEGREE CONTRA ANGLE SCREWDRIVER (PART# 24-1189, LOT# 191750 AND LOT# 252610) WERE VISUALLY EVALUATED. THEY WERE IN DECENT OVERALL CONDITION WITH SOME MINOR DISCOLORATION. FUNCTIONAL TESTING SHOWED THE KNOBS WERE STICKING SLIGHTLY DURING ROTATION. THE DRIVER WAS DISASSEMBLED FOR FURTHER INSPECTION AND IT WAS FOUND THAT THE INTERNAL GEARS WERE STRIPPED AND METAL SHAVINGS FELL OUT DURING DISASSEMBLY. DEVICE HISTORY RECORDS (DHR'S) WERE REVIEWED AND NO DISCREPANCIES WERE FOUND. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT WAS DUE TO THE GEARS BEING STRIPPED, LIKELY RESULTING FROM EXCESSIVE TORQUE DURING SCREW INSERTION. IN THE WARNINGS AND PRECAUTIONS SECTION OF THE INSTRUCTIONS FOR USE (IFU) FOR THIS PRODUCT IT IS STATED: AVOID UNDUE STRESS OR STRAIN WHEN HANDLING OR CLEANING INSTRUMENTS. THE DISCOLORATION IS MOST LIKELY DUE TO RESIDUAL FROM THE CLEANING PROCESS. 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. THE FOLLOWING SECTIONS WERE UPDATED: ETHNICITY. DATE OF THIS REPORT. DATE RECEIVED BY MANUFACTURER. TYPE OF REPORT AND FOLLOW-UP NUMBER. FOLLOW-UP TYPE. DEVICE EVALUATED BY MANUFACTURER . METHOD CODE. RESULTS CODE. CONCLUSIONS CODE . MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001032347-2018-00489-1.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). 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: 0001032347-2018-00489.

    Description of Event or Problem · 1

    IT WAS REPORTED TWO CONTRA ANGLE DRIVERS SEEMED TO HAVE "GEARS¿ SLIPPING AND WERE NOT WORKING WELL TO DRIVE THE SCREWS IN AS NECESSARY. THEY WOULD TURN FINE WHEN NO PRESSURE WAS APPLIED TO THEM, BUT WHEN THE SURGEON WAS TRYING TO DRIVE SCREWS THEY WERE NOT FUNCTIONING PROPERLY. THE SURGEON WAS ABLE TO WORK AROUND THE ISSUE USING THE EXTRA LONG REGULAR DRIVER BLADES. THERE WAS A SLIGHT DELAY OF APPROXIMATELY FIVE MINUTES AND NO INJURY TO THE PATIENT. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603437 90° CONTRA ANGLE DRIVER SCREWDRIVER HRS BIOMET MICROFIXATION N/A 252610

    Patients

    Seq Age Sex Outcome Treatment
    1