BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISTAL TARGETING DEVICE GAMMA3 DISTAL TARGETING R1.5

    MDR report key: 3119032 · Received May 19, 2013

    Report

    Report Number
    0009610622-2013-00267
    Event Type
    Malfunction
    Date Received
    May 19, 2013
    Date of Event
    April 23, 2013
    Report Date
    April 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

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

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE REPORTED ISSUE WAS NOT CONFIRMED. THE EVENT DESCRIPTION DEFINED THE DISTAL TARGETING DEVICE (DTD) TO BE THE PRIMARY PRODUCT. NO ASSOCIATED PRODUCTS WERE REPORTED. AN INVESTIGATION AND A REVIEW OF THE DHR WERE NOT POSSIBLE BECAUSE THE PRODUCT AND LOT CODE WERE NOT PROVIDED; THE ROOT CAUSE COULD NOT BE DETERMINED. A POSSIBLE ROOT CAUSE FOR THE FUNCTIONAL PROBLEM COULD BE THAT THE WASHERS INSIDE THE FIXATION MECHANISM WERE ROTATED AND CAUSED THE NON-FUNCTION OF THE FIXATION. 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. IF THE COMPLAINED DTD WAS MANUFACTURED PRIOR TO THE CHANGE REQUEST COULD NOT BE DETERMINED BECAUSE THE MANUFACTURING DATE IS UNKNOWN. A MORE PRECISE EVALUATION WAS NOT POSSIBLE DUE TO MISSING INFORMATION. NO DISCREPANCIES WERE DETECTED DURING RISK ANALYSIS REVIEW. DEVICE WILL NOT BE RETURNED.

    Description of Event or Problem · 1

    DURING T2 RECON NAIL W/S, WHEN CONNECTING THE DISTAL TARGETING ARM AND T2 RECON TARGET DEVICE, FIXATION BOLT COULD NOT INSERT TO THE DEVICE HOLE.

    Description of Event or Problem · 1

    DURING T2 RECON NAIL W/S, WHEN CONNECTING THE DISTAL TARGETING ARM AND T2 RECON TARGET DEVICE, FIXATION BOLT COULD NOT INSERT TO THE DEVICE HOLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221235 DISTAL TARGETING DEVICE GAMMA3 DISTAL TARGETING R1.5 INSTRUMENT LXH STRYKER OSTEOSYNTHESIS-KIEL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other