BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDLOCK SLEEVE GAMMA3 180

    MDR report key: 3132227 · Received May 29, 2013

    Report

    Report Number
    0009610622-2013-00290
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    May 3, 2013
    Report Date
    May 3, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-KIEL
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    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 CONCLUSION: EVENT DESCRIPTION SUGGESTS THE SPEEDLOCK SLEEVE TO BE PRIMARY PRODUCT. NO ASSOCIATED PRODUCT REPORTED. DEVIATIONS IN THE MANUFACTURING DOCUMENTS WERE NOT FOUND. THE EVENT OF THE FALLEN OUT PIN IS MOST LIKELY CAUSED DUE TO AN INADEQUATE PRESS-FITTING BETWEEN PIN AND CORRESPONDING DRILL HOLE. A DEVIATION REPORT HAD ALREADY BEEN RAISED FOR CHANGE OF THE MANUFACTURING PROCESS VIA CHANGE REQUEST. THE DEVICE RETURNED WAS MANUFACTURED PRIOR ABOVE MENTIONED CAPA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE CHECKING IN AN INSTRUMENT SET, I NOTICED ONE OF THE PINS HAD FALLEN OUT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE CHECKING IN AN INSTRUMENT SET, I NOTICED ONE OF THE PINS HAD FALLEN OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235928 SPEEDLOCK SLEEVE GAMMA3 180 INSTRUMENT LXH STRYKER OSTEOSYNTHESIS-KIEL KP302681

    Patients

    Seq Age Sex Outcome Treatment
    1 Other