BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIGEN

    MDR report key: 1891117 · Received November 4, 2010

    Report

    Report Number
    1020279-2010-00314
    Event Type
    Injury
    Date Received
    November 4, 2010
    Date of Event
    September 24, 2010
    Report Date
    December 21, 2010
    Manufacturer
    SMITH-NEPHEW INC.
    Product Code
    LXH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FRACTURE OF THE PILOT DRILL MOST LIKELY OCCURRED IN OVERLOAD. AN OVERLOAD FRACTURE CAN OCCUR IF THE MECHANICAL LOADS APPLIED TO THE DRILL EXCEED THE STRENGTH OF THE MATERIAL. THE REPORT SAYS THAT "THE DRILL BROKE WHEN IT CONTACTED THE SCREW HOLE". THE SURGICAL TECHNIQUE RECOMMENDS CHECKING THE ALIGNMENT OF THE DRILL IN THE NAIL PRIOR TO INSERTION IN THE BODY TO VERIFY TARGETING ACCURACY. NO MATERIAL OR MANUFACTURING DEVIATIONS WERE FOUND IN THIS INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SURGERY TIME WAS EXTENDED DUE TO A BROKEN DRILL BIT.

    Description of Event or Problem · 1

    DURING PROCEDURE THE COIL WAS INSERTED INTO THE ANEURYSM. THE POWER SUPPLY SIGNALED COIL DETACHMENT, HOWEVER, AS THE PHYSICIAN MOVED THE PUSHERWIRE HE NOTED THE COIL WAS STILL ATTACHED AND A PORTION OF THE COIL PROTRUDED OUTSIDE THE ANEURYSM. THE PHYSICIAN DECIDED TO REMOVE THE COIL FROM THE PATIENT. HOWEVER, AS THE COIL WAS RETRACTED INTO THE MICROCATHER IT SUDDENLY DETACHED. THE COIL WAS RETRIEVED WITH A SNARE AND THE PROCEDURE COMPLETED WITH A DIFFERENT DEVICE. IT WAS REPORTED THAT THE PATIENT DID NOT SUFFER ANY SERIOUS INJURY BUT HAD "LITTLE MOTORICAL PROBLEMS" THAT THE PHYSICIAN EXPECTED TO FULLY RESOLVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIGEN PILOT DRILL LXH SMITH-NEPHEW INC. 10DM04801

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R