BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIM-ARM 130° F/PFNA BLADE

    MDR report key: 3771322 · Received April 24, 2014

    Report

    Report Number
    9612488-2014-10124
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Report Date
    March 27, 2014
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    FZX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    ADDITIONAL NARRATIVE: (B)(6). SERVICE HISTORY REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE DEVICE HAS NOT BEEN SERVICED DURING THE PAST 6 MONTHS. THERE IS NO INFORMATION RELEVANT TO THE CURRENT COMPLAINT ISSUE. THE INVESTIGATION IS BASED ON THE SERVICE & REPAIR RECORD RECEIVED. THE DEVICE FAILURE REPORTED BY THE CUSTOMER COULD BE CONFIRMED. THE SERVICE HISTORY REVIEW SHOWS NO PREVIOUS SERVICE CONDITIONS RELEVANT TO THE CURRENT COMPLAINT ISSUE. THE SERVICE TECHNICIAN NOTED THE FOLLOWING ACTION REPAIR. DURING THE PRE-REPAIR DIAGNOSTIC ASSESSMENT THE SERVICE TECHNICIAN IDENTIFIED THE FOLLOWING FAILURE FLAT SPRING OF THE LOCK-DEVICE IS WORN OUT. THE ROOT CAUSE OF THE EVENT WAS DETERMINED TO BE NORMAL WEAR. THE DEVICE WAS REPAIRED AND RETURNED TO CUSTOMER. 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

    IT WAS REPORTED THAT THE ARMING BLADE DOES NOT WORK. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248727 AIM-ARM 130° F/PFNA BLADE GUIDE FZX SYNTHES BETTLACH 2646885

    Patients

    Seq Age Sex Outcome Treatment
    1