BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIXATION BOLT GAMMA3 DISTAL TARGETING Ø9X50 MM

    MDR report key: 3092560 · Received May 3, 2013

    Report

    Report Number
    0009610622-2013-00046
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    January 23, 2013
    Report Date
    January 23, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-KIEL
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: IN THIS CASE THE ALLEGED MAL-FUNCTION COULD NOT BE REPRODUCED. THE INTERACTION OF THE AFFECTED ITEMS WAS NOT IMPAIRED AND WAS CONFIRMED BY TEST AT THE LOCAL DISTRIBUTION SITE. THUS, MANUFACTURING FAULTS WERE EXCLUDED. CONSEQUENTLY, THE EVENT WAS NOT CAUSED BY A DEFICIENCY OF THE DEVICES BUT MOST LIKELY CAUSED BY POOR CONNECTION AND / OR POOR ADJUSTMENT PRIOR TO USE. DEVICE WAS TESTED AT THE LOCAL DISTRIBUTION SITE.

    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 GAMMA3 LONG NAIL SURGERY, WHEN THE SURGEON DID THE CALIBRATION OF NAIL AND DISTAL TARGET DEVICE, THE DRILL CONTACTED THE NAIL. HE TRIED IT MANY TIMES, IT WAS SAME SITUATION. AFTER THAT OTHER LENGTH NAIL WAS USED AND THE SURGERY WAS FINISHED.

    Description of Event or Problem · 1

    DURING GAMMA3 LONG NAIL SURGERY, WHEN THE SURGEON DID THE CALIBRATION OF NAIL AND DISTAL TARGET DEVICE, THE DRILL CONTACTED THE NAIL. HE TRIED IT MANY TIMES, IT WAS SAME SITUATION. AFTER THAT OTHER LENGTH NAIL WAS USED AND THE SURGERY WAS FINISHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194738 FIXATION BOLT GAMMA3 DISTAL TARGETING Ø9X50 MM INSTRUMENT LXH STRYKER OSTEOSYNTHESIS-KIEL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other