BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE

    MDR report key: 2924488 · Received January 22, 2013

    Report

    Report Number
    1719045-2013-00162
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    December 27, 2012
    Report Date
    December 27, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    K011857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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 RECORDS HAS BEEN REQUESTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODE: HWC. A PRODUCT DEVELOPMENT EVALUATION WAS CONDUCTED AND THE REPORT INDICATES THE RETURNED DEVICES (HELICAL BLADE AND TROCHANTERIC FIXATION NAIL) 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, 130 DEGREE AIMING ARM, INSERTION HANDLE HELICAL BLADE COUPLING SCREW, HELICAL BLADE INSERTER, BLADE GUIDE SLEEVE, BUTTRESS/COMPRESSION NUT AND BALL HEX SCREWDRIVER. THE CONSTRUCT ASSEMBLED AND THE RETURNED HELICAL BLADE ALIGNED AND PASSED THROUGH THE RETURNED 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. A REVIEW OF SYNTHES DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES.

    Description of Event or Problem · 1

    THIS IS 1 OF 2 REPORTS FOR THE SAME EVENT, COMPLAINT #(B)(4).

    Description of Event or Problem · 1

    DURING A SHORT TFN NAIL PROCEDURE, THE CORTEX BUSTING DRILL WAS BINDING ON THE HOLE IN THE NAIL. THE HELICAL BLADE WOULD NOT ADVANCE THROUGH THE NAIL. SURGEON REMOVED THE NAIL AND BLADE, CHECKED THE LOCKING MECHANISM IN THE NAIL WHICH WAS IN THE CORRECT ORIENTATION. HE THEN TRIED TO ASSEMBLE THE NAIL AND BLADE ON THE BACK TABLE, AND THE PARTS WERE STILL BINDING. HE USED A NEW NAIL, BLADE AND TFN SET, AND COMPLETED THE PROCEDURE WITH NO FURTHER PROBLEM. A HALF AN HOUR WAS ADDED TO THE SURGICAL TIME. CONSULTANT NOTED THE NAIL WAS A NEW NAIL, AND WAS NOT A REPROCESSED NAIL. THIS IS 1 OF 2 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30383 11MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM-STERILE TI CANN TROCH FIXATION NAIL HSB SYNTHES MONUMENT 7030402

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Required Intervention HELICAL BLADE