BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM INSERTER SHORT

    MDR report key: 2924439 · Received January 22, 2013

    Report

    Report Number
    0001825034-2013-00124
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    December 19, 2012
    Report Date
    December 28, 2012
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HXX
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DIMENSIONAL EVALUATION FOUND COMPONENT TO BE WITHIN APPROPRIATE DESIGN SPECIFICATION. THE USE OF THIS INSTRUMENT OUTSIDE OF IT'S INTENDED USE LED TO INSTRUMENT FRACTURE.THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER PRECAUTIONS, IT STATES, "SURGICAL INSTRUMENTS SHOULD ONLY BE USED FOR THEIR INTENDED PURPOSE."

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. DEVICE AVAILABILITY - THE DEVICE IS REPORTED TO BE AVAILABLE FOR EVALUATION; HOWEVER, IT HAS NOT BEEN RECEIVED BY BIOMET ORTHOPEDICS TO DATE. IN THE EVENT THAT THE DEVICE IS RECEIVED AND EVALUATED, A FOLLOW UP REPORT WILL BE SENT TO THE FDA TO PROVIDE RESULTS.

    Additional Manufacturer Narrative · 1

    (B)(4). REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A TRAUMA PROCEDURE UTILIZING A PHOENIX TIBIA NAIL ON (B)(6) 2012. WHEN THE SURGEON WAS USING THE HEX DRIVER WITH THE END CAP, THE TIP OF THE DRIVER FRACTURED AND REMAINED IN THE END CAP. THE SURGEON WAS ABE TO RETRIEVE THE PIECE AND A SOLID DRIVER WAS USED TO FINISH THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31059 3.5MM INSERTER SHORT ORTHOPEDIC MANUAL SURGICAL INSTRUMENT HXX BIOMET ORTHOPEDICS N/A 913930

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R