BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM INSERTER CONNECTOR LONG

    MDR report key: 3009486 · Received March 18, 2013

    Report

    Report Number
    0001825034-2013-00633
    Event Type
    Injury
    Date Received
    March 18, 2013
    Date of Event
    February 12, 2013
    Report Date
    February 19, 2015
    Manufacturer
    BIOMET
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF RETURNED DEVICE FOUND EVIDENCE THAT INSTRUMENT FRACTURED DUE TO TORSIONAL OVERLOAD. DIMENSIONAL EVALUATION FOUND COMPONENT TO BE WITHIN APPROPRIATE DESIGN SPECIFICATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER PRECAUTIONS, IT STATES, "SURGICAL INSTRUMENTS ARE SUBJECT TO WEAR WITH NORMAL USAGE. INSTRUMENTS, WHICH HAVE EXPERIENCED EXTENSIVE USE OR EXCESSIVE FORCE, ARE SUSCEPTIBLE TO FRACTURE. SURGICAL INSTRUMENTS SHOULD ONLY BE USED FOR THEIR INTENDED PURPOSE. BIOMET RECOMMENDS THAT ALL INSTRUMENTS BE REGULARLY INSPECTED FOR WEAR AND DISFIGUREMENT. " THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-00633-1 / 00634-1).

    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. (B)(4) HAS BEEN ASSIGNED. THE CAPA WILL DETERMINE THE ROOT CAUSE OF THE COMPLAINT AND ADDRESS APPROPRIATE CORRECTIVE ACTIONS TAKEN.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY CORRECTED PRODUCT EVALUATION RESULTS. EXAMINATION OF RETURNED DEVICE FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCE. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED, BUT WAS LIKELY DUE TO ACCIDENTAL USE OF THE INSERTER CONNECTOR DURING THE TORQUING PORTION OF THE PROCEDURE.

    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. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-00633 / 00634).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A TRAUMA PROCEDURE ON (B)(6) 2013. DURING THE PROCEDURE, WHILE THE SURGEON WAS ATTEMPTING TO INSERT THE SCREW INTO THE FEMUR THE INSERTER CONNECTOR FRACTURED AND THE SCREW REMAINED IN THE FEMUR. THE SURGEON RETRIEVED THE SCREW BUT AS A RESULT USED A DIFFERENT SCREW AND A SHORTER SCREWDRIVER TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112932 3.5MM INSERTER CONNECTOR LONG ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH BIOMET N/A RS08A013

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R