BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISTAL TARGETING DEVICE GAMMA3 DISTAL TARGETING R1.5

    MDR report key: 3151329 · Received June 7, 2013

    Report

    Report Number
    0009610622-2013-00313
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 14, 2013
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE RETURNED DEVICE MATCHED THE REPORT AND THE REPORTED EVENT WAS CONFIRMED. REVIEW OF THE DHR / INSPECTION RECORDS REVEALED NO DISCREPANCIES. THE ITEM RETURNED WAS DOCUMENTED AS HAVING MET SPECIFICATIONS PRIOR TO DISTRIBUTION. UPON RECEIPT THE METAL WASHERS OF THE FIXATION / CLAMPING MECHANISM WERE FOUND ROTATED TO AN INCORRECT POSITION. THUS, CLAMPING FUNCTION WAS RESTRICTED. IN THIS CONDITION, THE REPORTED ISSUE ¿WHEN CONNECTING THE DISTAL TARGETING DEVICE AND G3 TARGET ARM, FIXATION BOLT COULD NOT INSERT TO THE DEVICE HOLE¿ COULD BE REPRODUCED WITH A SAMPLE GAMMA3 TARGET DEVICE. THE FIXATION BOLT COULD NOT BE INSERTED AND THE FIXATION LEVER COULD NOT BE LOCKED EASILY. AFTER RE-POSITIONING THE (ROTATED) WASHERS AS INTENDED, THE RETURNED DTD COULD BE ASSEMBLED WITH THE SAMPLE GAMMA3 TARGET DEVICE AS SPECIFIED; THE FIXATION BOLT COULD BE INSERTED COMPLETELY AND THE FIXATION LEVER COULD BE LOCKED WITHOUT PROBLEMS. A CHANGE WAS PERFORMED TO REPLACE THE METAL WASHERS WITH A CUSHION WASHER IN ORDER TO OPTIMIZE THE FIT AND TO ENSURE PROPER CLAMPING FUNCTION. NO NON-CONFORMITY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    DURING G3 LONG NAIL SURGERY, WHEN CONNECTING THE DISTAL TARGETING DEVICE AND G3 TARGET ARM, FIXATION BOLT COULD NOT INSERT TO THE DEVICE HOLE. THEREFORE THE SURGEON USED THE RADIOLUCENT DRILL. THE SURGERY WAS COMPLETED.

    Description of Event or Problem · 1

    DURING G3 LONG NAIL SURGERY, WHEN CONNECTING THE DISTAL TARGETING DEVICE AND G3 TARGET ARM, FIXATION BOLT COULD NOT INSERT TO THE DEVICE HOLE. THEREFORE THE SURGEON USED THE RADIOLUCENT DRILL. THE SURGERY WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252456 DISTAL TARGETING DEVICE GAMMA3 DISTAL TARGETING R1.5 INSTRUMENT LXH STRYKER TRAUMA KIEL KP332478

    Patients

    Seq Age Sex Outcome Treatment
    1 Other