BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    130 DEG AIMING ARM F/TROCHANTERIC FIXATION NAILS

    MDR report key: 2806444 · Received October 26, 2012

    Report

    Report Number
    2530088-2012-00963
    Event Type
    Malfunction
    Date Received
    October 26, 2012
    Date of Event
    September 30, 2012
    Report Date
    September 30, 2012
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    JDS
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DHR WAS REVIEWED AND MRR #(B)(4) WAS FOUND ON P/N (B)(4), LOT #4762687 FOR INCORRECT AQL QUANTITY PROVIDED ON THE VENDOR INSPECTION REPORT. QA INSPECTED THE LOT OF PARTS AT THE CORRECT AQL QUANTITY AND THEY PASSED AND WERE ACCEPTED BY THE (B)(4). MRR #(B)(4) WERE FOUND ON P/N (B)(4) LOT #4762733. MRR #(B)(4) WAS FOUND FOR FEATURE (B)(4) OVERSIZE, NICKS AND NIBS FOUND ON THE SUPPLIER PARTS. THE PARTS WERE RETURNED TO THE SUPPLIER, REWORKED, INSPECTED 100% AND PASSED FOR ALL NON CONFORMANCES. MRR# (B)(4) WAS FOUND FOR FEATURE (B)(4) OVERSIZE. ALL PARTS WERE RE-INSPECTED 100% FOR (B)(4). THE PARTS WERE ACCEPTED USE AS IS BY THE (B)(4) BECAUSE A BORE OF (B)(4) WILL NOT AFFECT THE SAFETY OR EFFICACY. MRR #(B)(4) WAS INCLUDED AS A REFERENCE. MRR #(B)(4) WAS FOUND ON P/N (B)(4), LOT #4814787 FOR SUPPLIER CERTIFICATE OF CONFORMANCE FOR MATERIAL AND HARDNESS NOT RECEIVED WITH THE PARTS. THE SUPPLIER PROVIDED THE CERTIFICATES FOR MATERIAL AND HARDNESS AND THE (B)(4) ACCEPTED THE PARTS. MRR #(B)(4) WERE FOUND ON P/N (B)(4), LOT #4973551. MRR #(B)(4) WAS FOUND FOR FEATURE (B)(4) ACCEPTING THE NO GO THREAD GAGE. THE PARTS WERE CHECKED 100% FOR (B)(4) AND ONE NONCONFORMING PART WAS FOUND AND SCRAPPED. MRR #(B)(4) WAS FOUND FOR FEATURE (B)(4) OVERSIZE AND POOR FINISH. FEATURE (B)(4) IS INSPECTED 100% AND THE ONE NONCONFORMING PART FOUND FOR (B)(4) WAS SCRAPPED. THE FINISH ISSUE WAS DETERMINED TO BE ACCEPTABLE ON ALL PARTS BY THE (B)(4) AND ALL PARTS WERE ACCEPTED. THE NON CONFORMANCES FOUND IN THIS DHR REVIEW ARE NOT RELEVANT TO THE COMPLAINT CONDITION. THE PRODUCT HAS NOT BEEN RETURNED FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 1

    DURING A TFN PROCEDURE, A CONSTRUCT CONSISTING OF 130 DEGREES AIMING ARM, BUTTRESS COMPRESSION NUT, AND BLADE GUIDE SLEEVE ENCOUNTERED A PROBLEM. THE AIMING ARM SLIPPED AS THE BUTTRESS COMPRESSION NUT ALONG WITH THE BLADE GUIDE SLEEVE KEPT DISENGAGING FROM THE AIMING ARM. SURGEON HAD TO KEEP ENGAGING THE COMPRESSION NUT AND BLADE GUIDE SLEEVE TO COMPLETE THE PROCEDURE. THIS ADDED A 10 TO 15 MINUTE DELAY, THE PROCEDURE WAS COMPLETED WITH NO ADVERSE EFFECT TO THE PATIENT NOTED. THIS IS 3 OF 3 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 130 DEG AIMING ARM F/TROCHANTERIC FIXATION NAILS 130 DEG AIMING ARM JDS SYNTHES BRANDYWINE 5016997

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR BLADE GUIDE SLEEVE, COMPRESSION NUT, AIMING ARM