BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    130 DEG AIMING ARM F/TROCHANTERIC FIXATION NAILS

    MDR report key: 3961567 · Received July 28, 2014

    Report

    Report Number
    2530088-2014-10192
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Report Date
    June 30, 2014
    Manufacturer
    SYNTHES BRANDYWINE
    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

    EVENT DATE: UNKNOWN. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. THE REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED: NO ISSUES WERE FOUND DURING MANUFACTURE THAT WOULD CONTRIBUTE TO THE 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 PRODUCT EVALUATION WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES HAS SHOWN THAT BASED ON THE DESIGN EVALUATION IT APPEARS THAT THE COMPLAINT CONDITION WAS DUE TO PRIOR DAMAGE DUE TO ERRANT HAMMER BLOWS AND NOT A DESIGN DEFICIENCY. ALL RETURNED PARTS ARE DETERMINED TO BE SUITABLE FOR THEIR INTENDED USE WHEN USED AND MAINTAINED AS RECOMMENDED. THIS COMPLAINT IS CONFIRMED, AND THE DESIGN OF THE DEVICE DID NOT CONTRIBUTE TO THIS COMPLAINT. THE DRAWING(S) FOR THE INSTRUMENT(S) WERE REVIEWED AND ARE DETERMINED TO BE SUITABLE FOR THE DESIGN AND RELATED DIMENSIONAL CONFORMITY. THE DEVICES HAVE SEEN APPROX. 11 YEARS OF SERVICE. THE AIMING ARMS HAVE BEEN WELL USED, WITH NUMEROUS SCRATCHES, GOUGES, AND HAMMER MARKS; ADDITIONALLY, THE ANODIZATION IS REMOVED IN MANY LOCATIONS. THE KNOBS ARE ATTACHED TO BOTH AIMING ARMS AND BOTH APPEAR TO FUNCTION AS DESIGNED. THE BUTTRESS NUT HAS SIGNIFICANT GOUGING AND MARKS ON THE EXTERNAL KNURLED RADIUS. THE MARKS ON ALL THREE INSTRUMENTS APPEAR TO BE THE RESULT OF ERRANT HAMMER BLOWS. THE RETURNED INSTRUMENTS ARE PART OF THE TROCHANTERIC FIXATION NAIL SYSTEM (TFN) AND THEIR PROPER USE AND MAINTENANCE IS ADDRESSED IN TECHNIQUE GUIDES J9516-C AND J3900-I. THE RETURNED PARTS WERE ASSEMBLED WITH KNOWN GOOD PARTS IN THE CHU (PART # 357.369 / LOT # 4545108) AND THE COMPLAINT CONDITION WAS REPLICATED. THE COMPLAINT CONDITION IS CONFIRMED AND DUE TO PRIOR DAMAGE TO THE INSTRUMENT FROM ERRANT HAMMERS BLOWS AND NOT A RESULT OF THE DESIGN OF THE DEVICE. BASED ON THE DESIGN EVALUATION IT APPEARS THAT THE COMPLAINT CONDITION WAS DUE TO PRIOR DAMAGE DUE TO ERRANT HAMMER BLOWS AND NOT A DESIGN DEFICIENCY. ALL RETURNED PARTS ARE DETERMINED TO BE SUITABLE FOR THEIR INTENDED USE WHEN USED AND MAINTAINED AS RECOMMENDED. THIS COMPLAINT IS CONFIRMED, AND THE DESIGN OF THE DEVICE DID NOT CONTRIBUTE TO THIS COMPLAINT. 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 TROCHANTERIC FIXATION NAIL COMPONENTS ARE NOT FUNCTIONING PROPERLY. IT WAS REPORTED THAT THE BUTTRESS NUT ENGAGES WITH THE AIMING ARMS BUT AFTER DOES NOT DISENGAGE. THE EVENT IS NOT RELATED TO A PATIENT OR CASE. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439143 130 DEG AIMING ARM F/TROCHANTERIC FIXATION NAILS GUIDE FZX SYNTHES BRANDYWINE 4438938

    Patients

    Seq Age Sex Outcome Treatment
    1