BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIM-ARM F/PFNA BLADE 130° F/SMALL+EXTRA-

    MDR report key: 3924329 · Received July 9, 2014

    Report

    Report Number
    9612488-2014-10272
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    June 11, 2012
    Report Date
    June 12, 2014
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    FZX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    A MANUFACTURING EVALUATION WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES HAS SHOWN THAT THE RETURNED INSTRUMENTS WERE ANALYSED FOR CONFORMANCE TO PRINT SPECIFICATIONS AS WELL AS THE DEVICE HISTORY RECORDS WERE RESEARCHED. NO ABNORMAL FINDINGS WERE IDENTIFIED. FURTHER INVESTIGATION HAS SHOWN THAT THESE INSTRUMENTS WERE MANUFACTURED 5 TO 7 YEARS AGO. IT IS CLEARLY VISIBLE THAT ALL FOUR INSTRUMENTS HAVE BEEN HEAVILY USED OVER THE YEARS. NOTE THAT THE FUNCTIONALITY OF THE RETURNED ARTICLES IS STILL GIVEN (DRY TESTS) THOUGH. BASED ON THESE FINDINGS WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES AND WE DETERMINE THE COMPLAINED MALFUNCTION AS NORMAL WEAR AND TEAR AFTER FREQUENT USE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE PROXIMAL FEMORAL NAIL ANTIROTATION INSTRUMENTS WORK FINE WHEN TESTING THEM, BUT IN SITU WITH SOFT TISSUE IT BOUNCES AND DOES NOT KEEP THE MECHANISM. THE SURGEON MUST KEEP A HAND HELD AGAINST IT FOR IT TO WORK. THIS IS REPORT 2 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399962 AIM-ARM F/PFNA BLADE 130° F/SMALL+EXTRA- GUIDE FZX SYNTHES BETTLACH 2539013

    Patients

    Seq Age Sex Outcome Treatment
    1