BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.3 MM SQUARE SCREWDRIVER

    MDR report key: 3910351 · Received July 2, 2014

    Report

    Report Number
    0001825034-2014-05930
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    June 3, 2014
    Report Date
    July 30, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HXX
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION IN PROCESS BUT NOT YET COMPLETE. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. EXAMINATION OF RETURNED DEVICE FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCE. DURING THE EVALUATION, IT WAS DETERMINED PRODUCT LIKELY FAILED DUE TO MISUSE BY INSTRUMENT BEING PUT THROUGH EXCESSIVE FORCE OR OVER TORQUED, AND/OR NOT INSPECTED FOR WEAR AND DISFIGUREMENT WHICH MAY HAVE PREVENTED THE USE OF THE INSTRUMENT AND ITS FAILURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A RADIAL HEAD PLATING PROCEDURE UTILIZING A SQUARE DRIVER ON (B)(6) 2014. DURING THE PROCEDURE, THE SQUARE DRIVER FRACTURED IN THE HEAD OF THE SCREW AS IT WAS BEING INSERTED. THE SURGEON REMOVED THE SCREW. ANOTHER SQUARE DRIVER WAS AVAILABLE TO COMPLETE THE PROCEDURE; HOWEVER, THE SURGEON ENCOUNTERED DIFFICULTIES UTILIZING THE BACK-UP DRIVER AS WELL. THERE WAS NO INJURY TO THE PATIENT OR SIGNIFICANT DELAY TO THE PROCEDURE AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387751 1.3 MM SQUARE SCREWDRIVER SCREWDRIVER HXX BIOMET ORTHOPEDICS N/A CV0910-1

    Patients

    Seq Age Sex Outcome Treatment
    1