BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSERT-HANDLE LONG F/EXPERT FN

    MDR report key: 3183581 · Received June 22, 2013

    Report

    Report Number
    8030965-2013-03614
    Event Type
    Malfunction
    Date Received
    June 22, 2013
    Report Date
    July 26, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE EVALUATION REVEALED THAT THE PIN IS SHEARED OFF. THE FRACTURE FACE IS HOMOGENOUS WHICH INDICATES MATERIAL CONFORMITY. BASED ON THESE FINDINGS WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES. WE ASSUME THAT A LOOSE CONNECTION BETWEEN THE HANDLE AND NAIL CAUSED THIS OCCURRENCE. SUCH A LOOSE CONNECTION HAS THE EFFECT THAT THE FORCE IS ONLY APPLIED ONTO THE PIN, WHICH CAN LEAD TO A MECHANICAL OVERLOAD. THE HAMMER MARKS ALL OVER THE INSTRUMENT INDICATE THAT THIS WAS AN OFTEN AND INTENSE USED INSTRUMENT. SO WEAR AND TEAR COULD ALSO HAVE PLAYED A CERTAIN ROLE. NO PRODUCT FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PIN OF THE HANDLE SHEARED OFF. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284311 INSERT-HANDLE LONG F/EXPERT FN LXH SYNTHES GMBH 1692076

    Patients

    Seq Age Sex Outcome Treatment
    1