BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11MM/130 DEG TI CANN TROCH FIXATION NAIL 400MM/LEFT

    MDR report key: 4101857 · Received September 19, 2014

    Report

    Report Number
    1719045-2014-10455
    Event Type
    Injury
    Date Received
    September 19, 2014
    Report Date
    August 25, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    PK011857
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODE: HWC. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. REVIEW OF MANUFACTURING RECORDS HAS BEEN REQUESTED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    A REVIEW OF DEPUY SYNTHES MONUMENT DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES.DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BROKEN TROCHANTERIC FIXATION NAIL (TFN) AND HELICAL BLADE WERE REMOVED FROM THE PATIENT. THE DEVICES WERE ORIGINALLY IMPLANTED ON (B)(6) 2013. THE PATIENT HAS A MAJOR OSSEOUS DEFECT SECONDARY TO METASTATIC CANCER. THE TROCHANTERIC FIXATION NAIL (TFN) AND HELICAL BLADE WERE EXPLANTED ON (B)(6) 2014. THE TROCHANTERIC FIXATION NAIL (TFN) WAS BROKEN ON THE LATERAL SIDE THROUGH THE HELICAL BLADE HOLE. NO ISSUES WERE REPORTED FOR THE EXPLANTED HELICAL BLADE. THE SURGEON REVISED THE CONSTRUCT WITH A 14X400 TROCHANTERIC FIXATION NAIL (TFN) AND A 90MM LAG SCREW. ALL DEVICES WERE COMPLETELY EXPLANTED. NO SURGICAL DELAY OR PATIENT HARM WAS REPORTED. THIS IS REPORT NUMBER 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581708 11MM/130 DEG TI CANN TROCH FIXATION NAIL 400MM/LEFT ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES MONUMENT 7422369

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention