BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIMING ARM

    MDR report key: 3647353 · Received February 26, 2014

    Report

    Report Number
    8030965-2014-10005
    Event Type
    Malfunction
    Date Received
    February 26, 2014
    Date of Event
    February 5, 2014
    Report Date
    February 5, 2014
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    FZX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A PRODUCT DEVELOPMENT EVALUATION WAS COMPLETED: THE 130 DEG AIMING ARM F/TROCHANTERIC FIXATION NAILS WAS RECEIVED WITH SIGNS OF WEAR AND TEAR. SPECIFICALLY, THERE ARE SEVERAL SCRATCH MARKS ON PRODUCT AND SLIGHT DISCOLORATION ON GOLD RING. DURING THIS EVALUATION, THE RETURNED DEVICE WAS ASSEMBLED WITH KNOWN GOOD MATING INSTRUMENTS TO COMPLETE THE INSERTION CONSTRUCT IN ATTEMPT TO REPLICATE THE COMPLAINT DESCRIPTION. THE MATING KNOWN GOOD PARTS INCLUDED A BLADE GUIDE SLEEVE (PART#357.369, LOT# 6702210) AND COMPRESSION NUT (PART#357.371, LOT# 5013309). THE BLADE GUIDE SLEEVE WITH COMPRESSION NUT WAS INSERTED INTO THE RETURNED AIMING ARM AND THE LOCKING MECHANISM ON THE AIMING ARM WAS ABLE TO RETAIN AND RELEASE THE COMPRESSION NUT ON EACH ATTEMPT. THE COMPLAINT CONDITION COULD NOT BE REPLICATED DURING THIS EVALUATION. THE COMPRESSION NUT AND BLADE GUIDE SLEEVE WERE NOT RETURNED FOR EVALUATION; HOWEVER, A KNOWN GOOD BLADE GUIDE SLEEVE AND COMPRESSION NUT WERE UTILIZED DURING THIS EVALUATION, WHICH SHOWED THAT THE AIMING ARM WILL RETAIN AND RELEASE AS INTENDED. THE DESIGN IS ADEQUATE FOR ITS INTENDED USE AND DID NOT CONTRIBUTE TO THIS COMPLAINT CONDITION. THEREFORE, THIS COMPLAINT IS INVALID FROM A DESIGN PERSPECTIVE. 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

    THIS DEVICE IS 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

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. A REVIEW OF THE DEVICE HISTORY WAS PERFORMED AND NO COMPLAINT ISSUES WERE FOUND. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. 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 ON (B)(6) 2014, AN INSERTION SLEEVE WAS STICKING AND WAS HARD TO DISENGAGE FROM THE AIMING ARM (PART NUMBER 357.366). THERE WAS NO NOTICEABLE DAMAGE TO THE PART NOTICED PREOPERATIVELY. THERE WAS NO PATIENT INVOLVEMENT AND NO FURTHER INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 1 FOR COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118131 AIMING ARM GUIDE FZX SYNTHES HAGENDORF 1925132

    Patients

    Seq Age Sex Outcome Treatment
    1