BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    130 DEG AIMING ARM F/TROCHANTERIC FIXATION NAILS

    MDR report key: 3555240 · Received January 6, 2014

    Report

    Report Number
    2530088-2014-00001
    Event Type
    Malfunction
    Date Received
    January 6, 2014
    Date of Event
    December 16, 2013
    Report Date
    December 16, 2013
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. THE DHR WAS REVIEWED AND MRR #(B)(4) WAS FOUND ON RAW MATERIAL P/N 11051 LOT #5052338 FOR CERT DOES NOT HAVE COMPOUND "N". THE SUPPLIER PROVIDED THE CORRECT CERT AND THE MATERIAL WAS ACCEPTED. THIS NONCONFORMANCE IS NOT RELEVANT TO THIS COMPLAINT BECAUSE THE ISSUE IS DOCUMENTATION. MRR #(B)(4) WAS FOUND ON P/N DG10052 LOT #5307889 FOR GO GAGE DOESN'T FIT. THE QE ACCEPTED THE PARTS AS CONFORMS BECAUSE THERE IS A HIGH SPOT ON THE GO PIN OF (B)(4) WHICH WOULD NOT ALLOW THE PIN TO GO. PARTS PASSED PER A DIFFERENT 7.03 PIN GAGE. THIS NONCONFORMANCE IS NOT RELEVANT TO THIS COMPLAINT BECAUSE THE ISSUE IS ON THE KNOB COMPONENT THAT WOULD NOT CAUSE MISALIGNMENT ISSUE. MRR #(B)(4) WAS FOUND ON P/N E1062 LOT #5098910 FOR MATERIAL AND HEAT TREAT CERT NOT RECEIVED. THE MATERIAL WAS ACCEPTED USE AS IS BY THE PRODUCT DEVELOPMENT ENGINEER BECAUSE 304 IS IN THE 18-8 FAMILY AND MATERIAL COMPOSITION MATCHES THAT REQUIRED PER THE SPEC LISTED ON THE DRAWING AND THEREFORE ACCEPTABLE. THIS NONCONFORMANCE IS NOT RELEVANT TO THE COMPLAINT BECAUSE THE ISSUE IS DOCUMENTATION. NO ISSUES WERE FOUND DURING MANUFACTURE THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. UNKNOWN DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TROCHANTERIC FIXATION NAIL PROCEDURE, WHEN DRILLING FOR THE DISTAL HOLE, THE DRILL BIT CAME IN CONTACT WITH THE NAIL. THE SURGEON THEN TOOK DRILL BIT UNHOOKED DRILL BIT FROM THE DRILL AND WAS ABLE TO TAP IT THROUGH WITH A MALLET TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT INJURY. THERE WAS NO DELAY REPORTED IN COMPLETING THE PROCEDURE. THIS IS REPORT 1 OF 5 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6570 130 DEG AIMING ARM F/TROCHANTERIC FIXATION NAILS FZX SYNTHES BRANDYWINE 5445554

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR