BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSERT-HANDLE F/EXPERT TN+FN

    MDR report key: 2903314 · Received January 9, 2013

    Report

    Report Number
    8030965-2013-00068
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Report Date
    December 11, 2012
    Manufacturer
    SYNTHES GMBH
    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

    THE DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS.

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. INVESTIGATION COORDINATED BY SYNTHES (B)(4). REPORT RECEIVED INDICATES THE PRESENT INSERTION HANDLE WAS ANALYZED FOR CONFORMANCE TO PRINT SPECIFICATIONS AS WELL AS THE DEVICE HISTORY RECORD WAS RESEARCHED, NO ABNORMAL FINDINGS WERE IDENTIFIED. MANUFACTURING AND INSPECTION RECORDS INDICATED NO PROBLEMS WITH THE LOT IN QUESTION. THE FRACTURE FACE IS HOMOGENOUS WHICH INDICATES MATERIAL CONFORMITY. WE DO SUPPOSE THAT A MECHANICAL OVERLOAD POSSIBLY FORCEFUL HAMMER BLOWS, IN COMBINATION WITH A LOOSE CONNECTION WITH THE NAIL, CAUSED THIS BREAKAGE. BASED ON THESE FINDINGS WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES. NO PRODUCT FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM SYNTHES (B)(6) PROVIDES INFORMATION FROM A FACILITY IN (B)(6) REGARDING AN INSERTION HANDLE. IT WAS REPORTED THAT THE PIN IS BROKEN. NO DETAILS REGARDING THE PROCEDURE OR PATIENT WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10426 INSERT-HANDLE F/EXPERT TN+FN STANDARD INSERTION HANDLE LXH SYNTHES GMBH 3050735

    Patients

    Seq Age Sex Outcome Treatment
    1