BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLADE GUIDE SLEEVE FOR TROCHANTERIC FIXATION NAILS

    MDR report key: 2912544 · Received January 13, 2013

    Report

    Report Number
    1719045-2013-00104
    Event Type
    Injury
    Date Received
    January 13, 2013
    Report Date
    December 16, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    KTT
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. AIMING ARM, INSERTION HANDLE, HELICAL BLADE INSERTER THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES.

    Additional Manufacturer Narrative · 1

    PRODUCT DEVELOPMENT ENGINEER EVALUATED THE DEVICES AND THE RETURNED DEVICES (INSERTION HANDLE, AIMING ARM, BLADE GUIDE SLEEVE AND HELICAL BLADE INSERTER) WERE ASSEMBLED WITH KNOWN GOOD MATING INSTRUMENTS AND IMPLANTS TO COMPLETE THE INSERTION CONSTRUCT IN ORDER TO EVALUATE THE ALIGNMENT OF THE RETURNED DEVICES. THE MATING KNOWN GOOD PARTS INCLUDED A CANNULATED CONNECTING SCREW (PART#357.397, LOT#4546891), TROCHANTERIC FIXATION NAIL (PART#456.315, LOT#6700338), HELICAL BLADE (PART#456.305), HELICAL BLADE COUPLING SCREW (PART#357.377, LOT#4818089), AND BALL HEX SCREWDRIVER (357.515, LOT#4936924). THE CONSTRUCT ASSEMBLED AND THE HELICAL BLADE ALIGNED AND PASSED THROUGH THE TFN AS INTENDED. THERE WERE NO ALIGNMENT ISSUES EXPERIENCED DURING THIS EVALUATION, THEREFORE THE COMPLAINT CONDITION COULD NOT BE REPLICATED. THE DESIGN IS ADEQUATE FOR ITS INTENDED USE AND DID NOT CONTRIBUTE TO THIS COMPLAINT CONDITION.

    Description of Event or Problem · 1

    DURING A TFN NAIL IMPLANT PROCEDURE, THE HELICAL BLADE WOULD NOT ADVANCE THROUGH THE NAIL. REPORTEDLY TWO SEPARATE NAILS WERE TRIED WITHOUT SUCCESS. ACCORDING TO THE SALES CONSULTANT, THERE WERE FOUR PIECES OF INSTRUMENTATION THAT WAS AFFECTING THE ISSUE. IT WAS REPORTED THERE WAS SOMETHING IN THE FOUR PIECES THAT WOULD NOT ALLOW IT TO ALIGN CORRECTLY. THE SURGEON HAD TO HALFWAY DISASSEMBLE THE INSTRUMENTATION TO ALLOW FOR MORE FLEXIBILITY THAT WOULD LET THE BLADE GO THROUGH THE NAIL. ONCE THE SURGEON DID THIS, HE WAS ABLE TO SUCCESSFULLY COMPLETE THE IMPLANT. THE SURGERY WAS PROLONGED APPROXIMATELY THIRTY MINUTES. THIS IS 3 OF 4 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19477 BLADE GUIDE SLEEVE FOR TROCHANTERIC FIXATION NAILS BLADE GUIDE SLEEVE KTT SYNTHES MONUMENT 6819624

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention