BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM INSERTER SHORT

    MDR report key: 2924425 · Received January 22, 2013

    Report

    Report Number
    0001825034-2013-00131
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    December 12, 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
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    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

    EVALUATION OF DEVICE FOUND EVIDENCE THAT FRACTURE WAS DUE TO EXCESSIVE FORCE. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER CARE AND HANDLING IT STATES, "PRIOR TO USE, INSTRUMENTS SHOULD BE VISUALLY INSPECTED AND FUNCTION SHOULD BE TESTED TO ASSURE INSTRUMENTS ARE FUNCTIONING PROPERLY. IF INSTRUMENTS ARE DISCOLORED, HAVE LOOSE SCREWS/PINS, ARE OUT OF ALIGNMENT, ARE CRACKED OR HAVE OTHER IRREGULARITIES, DO NOT USE."

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A TRAUMA PROCEDURE UTILIZING A PHOENIX FEMORAL 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 FRACTURED PIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30238 3.5MM INSERTER SHORT ORTHOPEDIC MANUAL SURGICAL INSTRUMENT HXX BIOMET ORTHOPEDICS N/A 294506

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R