BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIM-ARM 130° F/PFNA BLADE

    MDR report key: 3143467 · Received June 3, 2013

    Report

    Report Number
    8030965-2013-02642
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Report Date
    May 10, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    FZX
    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 NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO A DEVICE MARKETED IN THE USA. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE REVIEW ON THE BASIS OF THE MATERIAL AND MANUFACTURING DOCUMENTS OF THE PRESENT AIMING ARM SHOWS THAT ALL GUIDELINES ARE COMPLETELY CORRESPONDING ACCORDING TO THE AO / ASIF SPECIFICATIONS. UNFORTUNATELY IT IS NOT ELICITED AFTERWARDS, WHICH MECHANICAL FORCES WERE LEADING TO THIS DAMAGE. IT IS POSSIBLE THAT THE CENTERING PIVOTS WERE NOT INSTALLED RULE-CONSISTENT, THEREFORE UNDER THE PRESSURE THAT CAME FROM THE FIXATION OF THE LOCKING SCREW, THIS BREAKAGE OCCURRED. NO PRODUCT FAULT COULD BE DETECTED. PLACEHOLDER.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: ON AN UNKNOWN DATE, THE CONNECTING PIVOT BROKE OFF FROM THE PROXIMAL FEMORAL NAIL A (PFNA) AIMING ARM. IT IS UNKNOWN WHEN THIS OCCURRED. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243184 AIM-ARM 130° F/PFNA BLADE FZX SYNTHES GMBH 2782303

    Patients

    Seq Age Sex Outcome Treatment
    1