BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLADE GUIDE SLEEVE FOR TROCHANTERIC FIXATION NAILS

    MDR report key: 3052304 · Received April 11, 2013

    Report

    Report Number
    1719045-2013-00963
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 15, 2013
    Report Date
    March 15, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. NEMCOMED, PRESENTLY AVALIGN TECHNOLOGIES - NEMCOMED DIVISION, MANUFACTURED THE BLADE GUIDE SLEEVE FOR TROCHANTERIC FIXATION NAILS. THE PARTS WERE MADE TO THE CORRECT MATERIAL REQUIREMENTS, AND MET THE HARDNESS AND REQUIRED SPECIFICATIONS. THE LOT WAS INSPECTED AND CONFORMED TO THE SYNTHES, INCOMING FINAL INSPECTION SHEET. THERE WERE NO NON CONFORMANCES OR COMPLAINT RELATED ISSUES WITH THIS COMPLAINT. DURING THIS EVALUATION, THE RETURNED AIMING ARMS, QTY2, BLADE GUIDE SLEEVES, QTY 2, BUTTRESS-COMPRESSION NUTS, QTY 2, INSERTION HANDLES, QTY, 2, HELICAL BLADE COUPLING SCREWS, QTY 2, AND HELICAL BLADE INSERTERS, QTY 2, FROM THIS COMPLAINT WERE ASSEMBLED WITH KNOWN GOOD MATING INSTRUMENTS AND IMPLANTS TO COMPLETE THE INSERTION CONSTRUCT IN ORDER TO EVALUATE THE FUNCTION AND ALIGNMENT OF THE RETURNED DEVICES. THE MATING KNOWN GOOD PARTS INCLUDED A SHORT TROCHANTERIC FIXATION NAIL PART 456.315, LOT 6700338, CANNULATED CONNECTING SCREW PART 357.397, LOT 6606047, 100MM HELICAL BLADE PART 456.305, AND BALL HEX SCREWDRIVER PART 357.515, LOT 4936924. THE CONSTRUCTS ASSEMBLED AND THE HELICAL BLADE ALIGNED WITH THE TFN HOLE ON EACH ATTEMPT IN EACH COMBINATION MADE WITH THE RETURNED DEVICES. THE COMPLAINT CONDITION OF THE RETURNED DEVICES NOT ALIGNING COULD NOT BE REPLICATED DURING THIS EVALUATION. THE DESIGN IS ADEQUATE FOR ITS INTENDED USE AND DID NOT CONTRIBUTE TO THIS COMPLAINT CONDITION.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED AND REVIEWED; NO PRODUCT FAULT COULD BE DETECTED. THE DEVICE HISTORY REPORT STATES THAT THE SUPPLIER'S CERTIFICATE OF COMPLIANCE INDICATES THE PARTS WERE MADE TO THE CORRECT MATERIAL REQUIREMENTS, AND MET THE HARDNESS AND REQUIRED SPECIFICATIONS. THE LOT WAS INSPECTED AND CONFORMED TO THE SYNTHES, INCOMING FINAL INSPECTION SHEET. THERE WERE NO MRRS, NCRS, OR COMPLAINT RELATED ISSUES WITH THIS COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED ON (B)(4) 2013, THAT DURING A TFN PROCEDURE THE SURGEON EXPERIENCED DIFFICULTY FINDING ALIGNMENT FOR HELICAL BLADE INSERTION. AFTER 8 TO 10 ATTEMPTS AND SEVERAL PART INTERCHANGES, THE SURGEON WAS ABLE TO IMPLANT THE HELICAL BLADE WITHOUT RESISTANCE. PROCEDURE WAS COMPLETED TO THE SURGEON SATISFACTION WITH AN ADDITIONAL 20 MINUTES ADDED TO THE PROCEDURE. IT WAS ALSO REPORTED THAT THE SURGEON TECHNIQUE WAS NOT AN ISSUE AND HAD PERFORMED SEVERAL (100) TFN PROCEDURES. THIS REPORT IS FOR A BLADE GUIDE SLEEVE FOR TROCHANTERIC FIXATION NAILS. THIS IS 6 OF 12 PARTS FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155964 BLADE GUIDE SLEEVE FOR TROCHANTERIC FIXATION NAILS FZX SYNTHES MONUMENT 79419

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention