BEUDAMED
    FDA Adverse Event Injury Summary report: N

    12MM/130 DEG TI CANN TROCH FIXATION NAIL 235MM

    MDR report key: 2994089 · Received February 27, 2013

    Report

    Report Number
    1719045-2013-10084
    Event Type
    Injury
    Date Received
    February 27, 2013
    Date of Event
    January 22, 2011
    Report Date
    January 22, 2011
    Manufacturer
    SYNTHES (USA)
    Product Code
    HSB
    PMA / PMN Number
    K011857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADD'L INFO REC'D REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. THE SAMPLE WAS RETURNED WITH THE LOCKING PRONG BROKEN. WEAR TO THE INNER BORE OF THE OBLIQUE HEAD ELEMENT HOLE AND THE TANG OF THE ANTI-ROTATION LOCKING MECHANISM SHEARED OFF. A REVIEW OF MFG REPORTED CORRECT DEPTH AT TIME OF MFG REPORTED CORRECT DEPTH AT TIME OF MANUFACTURE. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW ANY CONDITIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE ANTI-ROTATION MECHANISM SHIFTED AFTER MANUFACTURE CAUSING THE REPORTED EVENT THUS CONCLUDING AN APPARENT DESIGN ISSUE. AN INTERNAL CORRECTIVE ACTION HAS BEEN OPENED TO ADDRESS THE ROOT CAUSE OF THE ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON ADVANCED THE HELICAL BLADE, THE LOCKING MECHANISM OF THE TROCHANTERIC FIXATION NAIL AND HELICAL BLADE DID NOT WORK. THE SURGEON TOOK AN X-RAY AND CONFIRMED THAT THE LOCKING MECHANISM IS DOWN AND THE PARTS ARE NOT LOCKED TOGETHER. THE HELICAL BLADE WAS DAMAGED. THE SURGEON REMOVED THE IMPLANTS AND USED NEW NAIL AND HELICAL BLADE TO COMPLETE THE PROCEDURE. THE INCIDENT PROLONGED THE SURGERY BY APPROX 30 MINS. PROCEDURE WAS COMPLETED SUCCESSFULLY AND PT WAS UNHARMED. THIS IS 1 OF 2 REPORTS THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84160 12MM/130 DEG TI CANN TROCH FIXATION NAIL 235MM HSB SYNTHES (USA) 6420746

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention