BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    90 DEGREE CONTRA ANGLE SCREWDRIVER

    MDR report key: 6048273 · Received October 21, 2016

    Report

    Report Number
    0001032347-2016-00603
    Event Type
    Malfunction
    Date Received
    October 21, 2016
    Date of Event
    September 23, 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
    NC, 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 PRODUCT WAS RETURNED FOR EVALUATION. THE PRODUCT IDENTITY WAS CONFIRMED IN THE EVALUATION. THE DEVICE HISTORY RECORDS WERE REVIEWED IN THE EVALUATION AND NO NON-CONFORMANCES WERE FOUND. THE DRIVER WAS VISUALLY EVALUATED AND SHOWS SIGNS OF NORMAL USE. THE DRIVER WAS FUNCTIONALLY TESTED AND COULD NOT INSERT THE SCREW. THE DRIVER BENDS WHEN ATTEMPTING TO INSERT THE SCREW. THE COMPLAINT WAS CONFIRMED AS THE DRIVER CANNOT INSERT A SCREW AS INTENDED. THE MOST LIKELY UNDERLYING CAUSE OF THE COMPLAINT WAS DETERMINED TO BE EXCESSIVE TORQUE APPLIED TO THE DRIVER. THIS IS REPORT TWO OF TWO FOR THE SAME EVENT. REPORT ONE OF TWO IS REPORTED ON MFR #0001032347-2016-00596-3.

    Additional Manufacturer Narrative · 1

    THE WARNINGS IN THE PACKAGE INSERT STATE THIS TYPE OF EVENT CAN OCCUR. 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. THIS IS REPORT TWO OF TWO FOR THE SAME EVENT. REPORT ONE OF TWO IS REPORTED ON MFR #0001032347-2016-00596 AND 0001032347-2016-00596-1.

    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 THAT DURING A RIBFIX PROCEDURE, TWO CRONTRA-ANGLE SCREWDRIVERS LOCKED UP DURING USE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DRIVER. IT IS REPORTED THAT THERE WAS NO DELAY OVER THIRTY MINUTES AND NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700095 90 DEGREE CONTRA ANGLE SCREWDRIVER SCREWDRIVER HRS BIOMET MICROFIXATION N/A 613200

    Patients

    Seq Age Sex Outcome Treatment
    1