BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISTAL TARGETING DEVICE GAMMA3 DISTAL TARGETING R1.5

    MDR report key: 3092546 · Received May 3, 2013

    Report

    Report Number
    0009610622-2013-00233
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 9, 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: THE REPORTED ISSUE WAS NOT CONFIRMED. EVALUATION REVEALED THE DTD TO BE THE PRIMARY PRODUCT. NO ASSOCIATED PRODUCTS WERE REPORTED. NO DEVIATIONS WERE FOUND DURING REVIEW OF THE MANUFACTURING AND INSPECTION DOCUMENTS (DHR). THE ITEM RETURNED WAS DOCUMENTED AS FAULTLESS PRIOR TO DISTRIBUTION. ALL WASHERS WERE FOUND IN THEIR CORRECT POSITION AND A ASSEMBLING TO A SAMPLE PROXIMAL GAMMA3 TARGET DEVICE WAS POSSIBLE LIKE SPECIFIED. THE EVENT DESCRIPTION INCLUDES THAT THE SURGEON PUSHED THE WASHERS BACK INTO CORRECT POSITION; THEREFORE THE REPORTED ISSUE COULD NOT BE CONFIRMED AND NOT REPRODUCED. HOWEVER, A CHANGE REQUEST WAS PERFORMED TO REPLACE THE WASHERS TO AN ELASTIC ELEMENT WITH THE SAME GEOMETRIES. THE CHANGE REQUEST BECAME EFFECTIVE IN MAY 2013, TO A TIME WHERE THE RETURNED DTD WAS ALREADY MANUFACTURED. NO DISCREPANCIES WERE DETECTED DURING RISK ANALYSIS REVIEW. NO NON-CONFORMITY IDENTIFIED; ACTIONS ARE IN PLACE.

    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 T2 RECON NAIL SURGERY, WHEN CONNECTING THE DISTAL TARGETING ARM AND T2 RECON TARGET DEVICE, FIXATION BOLT COULD NOT INSERT TO THE DEVICE HOLE. WHEN THE SURGEON CHECKED DTD, THE INTERNAL WASHER OF DTD HAD ROTATED AND HINDERED CONNECTION. THE SURGEON USED THE INSTRUMENT AND PUSHED IN THE WASHER. THE SURGERY WAS COMPLETED.

    Description of Event or Problem · 1

    DURING T2 RECON NAIL SURGERY, WHEN CONNECTING THE DISTAL TARGETING ARM AND T2 RECON TARGET DEVICE, FIXATION BOLT COULD NOT INSERT TO THE DEVICE HOLE. WHEN THE SURGEON CHECKED DTD, THE INTERNAL WASHER OF DTD HAD ROTATED AND HINDERED CONNECTION. THE SURGEON USED THE INSTRUMENT AND PUSHED IN THE WASHER. THE SURGERY WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194575 DISTAL TARGETING DEVICE GAMMA3 DISTAL TARGETING R1.5 INSTRUMENT LXH STRYKER OSTEOSYNTHESIS-KIEL KP355479

    Patients

    Seq Age Sex Outcome Treatment
    1 Other