BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APPLICAT OUT SHAFT

    MDR report key: 3030018 · Received April 2, 2013

    Report

    Report Number
    2520274-2013-01774
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Report Date
    March 4, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE WELD JOINT OF THE EXTERIOR SHAFT IS INDEED ERUPTED. WE ASSUME THAT TO HIGH MECHANICAL LOAD DURING THE INTERVENTION WAS LEADING TO THE DAMAGE OF THE WELDED JOINT. IN OUR ENDEAVOR FOR AN IMPROVEMENT OF OUR PRODUCT WE OPENED DCP 044361 TO STRENGTHEN THE WELDED JOINT. THIS ARTICLE CORRESPONDS WITH THE PREVIOUS DESIGN.

    Description of Event or Problem · 1

    THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE WELD ON THE T-PAL SPACER APPLICATOR HANDLE IS BROKEN OFF. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134242 APPLICAT OUT SHAFT LXH SYNTHES USA 3393607

    Patients

    Seq Age Sex Outcome Treatment
    1