BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    90 DEG CONTRA ANGLE SCREWDRIVER

    MDR report key: 6029184 · Received October 14, 2016

    Report

    Report Number
    0001032347-2016-00587
    Event Type
    Malfunction
    Date Received
    October 14, 2016
    Date of Event
    September 13, 2016
    Report Date
    December 7, 2018
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HRS
    PMA / PMN Number
    K142823
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS SUBMITTED TO CORRECT THE DEVICE PRODUCT CODE AND 510(K) NUMBER. THE FOLLOWING SECTIONS WERE CORRECTED: DEVICE PRODUCT CODE: JEY CORRECTED TO HRS. PMA/510(K) NUMBER: K121589 CORRECTED TO K142823. (B)(4).

    Additional Manufacturer Narrative · 1

    THE PRODUCTS WERE RETURNED FOR EVALUATION. THE PRODUCT IDENTITIES WERE CONFIRMED IN THE EVALUATION. THE DEVICE HISTORY RECORDS AND MATERIAL CERTIFICATIONS WERE REVIEWED AND NO NON-CONFORMANCES WERE FOUND. THE DRIVERS WERE VISUALLY EVALUATED AND THEY BOTH SHOW SIGNS OF NORMAL USE. THE DRIVERS WERE FUNCTIONALLY TESTED AND HAD NO ISSUES INSERTING AND REMOVING THE SCREW. THE DRIVERS WERE INSPECTED AND PASSED THE INSPECTION. THE COMPLAINT WAS UNCONFIRMED AS THE DRIVERS WERE ABLE TO INSERT A SCREW WITH NO ISSUES. THE MOST UNDERLYING CAUSE WAS DETERMINED TO BE USER ERROR. ACCORDING TO THE EVALUATION, THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS.

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF THE DEVICE EVALUATION.

    Description of Event or Problem · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THE GEARS IN THE ANGLED DRIVER APPEAR TO BE BROKEN AS THE DRIVER WOULD NOT TURN A SCREW COMPLETELY. THERE WAS A THREE MINUTE SURGICAL DELAY AS A SECOND DRIVER WAS AVAILABLE TO COMPLETE THE RIBFIX PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682537 90 DEG CONTRA ANGLE SCREWDRIVER 90 DEG CONTRA ANGLE SCREWDRIVER HRS BIOMET MICROFIXATION N/A 613200

    Patients

    Seq Age Sex Outcome Treatment
    1