BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIM-ARM 130° F/PFNA BLADE

    MDR report key: 2913853 · Received January 14, 2013

    Report

    Report Number
    8030965-2013-00135
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    November 4, 2012
    Report Date
    December 17, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. THE INSTRUMENT WAS ANALYZED FOR CONFORMANCE TO PRINT SPECIFICATIONS, AS WELL AS THE DEVICE HISTORY RECORDS WERE RESEARCHED. NO ABNORMAL FINDINGS WERE IDENTIFIED; THIS INSTRUMENT WAS MANUFACTURED ACCORDING TO THE SPECIFICATIONS. HOWEVER, PREVIOUSLY PERFORMED FUNCTIONAL TESTS HAVE SHOWN THAT THE LOCKING SLIDING INSERT OF THE PRESENT AIMING ARM MAY DISENGAGE DURING INSERTION OF THE PROTECTION SLEEVE WHILE ROTATING THE BUTTRESS COMPRESSION NUT CLOCKWISE. A DESIGN CHANGE HAS BEEN INITIATED TO ADDRESS THIS ISSUE.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM SYNTHES (B)(4) PROVIDES INFORMATION FROM A FACILITY IN (B)(6)REGARDING AN AIMING ARM. IT WAS REPORTED THAT IT WAS IMPOSSIBLE TO INSERT THE PROTECTION SLEEVE INTO THE AIMING ARM. REPORTEDLY, THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT, DELAY OF SURGERY WAS NOT SIGNIFICANT, THERE WAS A NEW AIMING ARM AVAILABLE AND THE INCIDENT DID NOT REQUIRE FURTHER TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19847 AIM-ARM 130° F/PFNA BLADE AIMING ARM LXH SYNTHES GMBH 7795370

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR