BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11.0MM TI HELICAL BLADE 90MM

    MDR report key: 3412217 · Received October 16, 2013

    Report

    Report Number
    3003506883-2013-00383
    Event Type
    Injury
    Date Received
    October 16, 2013
    Report Date
    September 18, 2013
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HSB
    PMA / PMN Number
    K011857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. : A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF 11MM TI HELICAL BLADES WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD REVEALED THIS LOT MET ALL SPECIFICATIONS WITH ONE NONCONFORMANCE NOTED. NON CONFORMANCE NCR (B)(4) WAS WRITTEN FOR A DOCUMENT ERROR. THE RAW MATERIAL CERTIFICATION WAS SUPPLIED WITH KSI UNITS USED FOR THE MECHANICAL TESTING AND THE REQUIREMENT IS FOR METRIC UNITS. THERE WAS NO ADVERSE EFFECT ON PRODUCT. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    SALES CONSULTANT REPORTED A SCHEDULED TROCHANTERIC FIXATION NAIL (TFN) SYSTEM REMOVAL ON (B)(6) 2013. PATIENT HAD PERSISTENT INFECTION OF WOUNDS AFTER IMPLANT SURGERY ON (B)(6) 2013. IT WAS REPORTED THAT THE PATIENTS SKIN AND BONE HAD NOT HEALED. THE TFN IMPLANTS INCLUDING THE 11.0MM TITANIUM HELICAL BLADE, 11MM 130 DEGREE TITANIUM CANNULATED TROCHANTERIC FIXATION NAIL 380MM/LEFT AND ONE, 5.0MM LOCKING SCREW 36MM FOR INTRAMEDULLAY NAILS WERE EXPLANTED ON SEPTEMBER 20, 2013. THE BONE CANAL WAS REAMED TO 13.5MM, THE PATIENTS WOUNDS WERE RINSED AND ANTIBIOTICS WERE ADMINISTERED AFTER CULTURES WERE COMPLETED. THIS COMPLAINT IS ON THE 11.0MM TITANIUM HELICAL BLADE. THIS IS 1 OF 3 REPORTS FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529576 11.0MM TI HELICAL BLADE 90MM HSB SYNTHES ELMIRA 7114716

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention