BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RECON LOCKING AIMING ARM FOR LATERAL ENTRY FEMORAL NAILS-EX

    MDR report key: 4245018 · Received November 12, 2014

    Report

    Report Number
    2530088-2014-10366
    Event Type
    Malfunction
    Date Received
    November 12, 2014
    Date of Event
    October 17, 2014
    Report Date
    October 17, 2014
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    FZX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. A DEVICE HISTORY REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE DHR WAS REVIEWED AND NCR #(B)(4) WAS FOUND ON P/N 03.010.048 LOT #5774136 FOR T1 ACCEPTS NO GO ON 1 OUT OF (B)(4) SUPPLIER PARTS. THE 1 NONCONFORMING PARTS WAS SCRAPPED. THIS NONCONFORMANCE IS NOT RELEVANT TO THE COMPLAINT CONDITION BECAUSE THE ISSUE IS ON THE M8 THREAD THAT IS WOULD NOT CAUSE THE SLEEVE TO GET STUCK. NCR #(B)(4) WAS FOUND ON P/N 03.010.048.5 LOT #5843627 FOR ITEM OUT TO 0.106, ITEM; OVERSIZE, ITEM; L6 OVERSIZE AND ITEM; OVERSIZE ON SUPPLIER PARTS. ITEMS 2 AND 4 WERE RE-INSPECTED USING MICROMETER AND ACCEPTED BY THE QE. ITEM 3 WAS RE-INSPECTED AND 1 FAILED OUT OF 47 PARTS AND WAS SCRAPPED. (B)(4) OUT OF (B)(4) WERE ACCEPTED USE AS IS BY THE PRODUCT DEVELOPMENT ENGINEER BECAUSE ITEM 1 IS A SURFACE PROFILE DESCRIBING A CAM LOCK FEATURE. SINCE THE STARTING DIMENSION OF THE CAM FEATURE (ITEM 4, 4.56-5.00) IS WITHIN THE SPECIFIED TOLERANCE, THE CONDITION OF ITEM 5 WILL STILL ALLOW THE CAM FEATURE TO FUNCTION. THIS NONCONFORMANCE IS NOT RELEVANT TO THE COMPLAINT CONDITION BECAUSE THE ISSUE IS ON THE CAM COMPONENT AND WOULD NOT CAUSE THE SLEEVE TO STICK IN THE AIMING ARM. 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE VISUAL INSPECTION OF THE RETURNED DEVICE PERFORMED AS PART OF THE PRODUCT INVESTIGATION REPORTED THE RETURNED AIMING ARM WAS RECEIVED SEPARATED FROM THE PROTECTION SLEEVES IDENTIFIED AS STICKING IN THE AIMING ARM. THE MATING PARTS WERE ALSO RECEIVED. ALL COMPONENTS FUNCTIONED AS DESIGNED WITHOUT ANY ISSUES. THE MANUFACTURE DATE IS NOVEMBER 5, 2009. PRODUCT DRAWINGS (03_010_048, REV E, AIMING ARM ASSEMBLY LATERAL ENTRY FEMORAL NAIL AND 03_010_048_1, REV H, AIMING ARM BODY LATERAL ENTRY FEMORAL NAIL) WERE REVIEWED DURING THIS EVALUATION. NO DRAWING DISCREPANCIES WERE IDENTIFIED. NO DAMAGE WAS FOUND AND THE PARTS FUNCTIONED AS INTENDED. THE DESIGN IS ADEQUATE FOR ITS INTENDED USE AND DID NOT CONTRIBUTE TO THIS COMPLAINT CONDITION. THE COMPLAINT IS UNCONFIRMED. 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 DURING A PROCEDURE, THE SLEEVES WERE GETTING STUCK AT THE AIMING ARM, THERE WAS DIFFICULTY GETTING THEM THROUGH. EVERYTHING ELSE WORKED FINE. THERE WAS A TIME DELAY OF 10 MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE PATIENT WAS DOING WELL. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    728425 RECON LOCKING AIMING ARM FOR LATERAL ENTRY FEMORAL NAILS-EX GUIDE FZX SYNTHES BRANDYWINE 6255597

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR