BEUDAMED
    FDA Adverse Event Injury Summary report: N

    12MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM

    MDR report key: 3954132 · Received July 23, 2014

    Report

    Report Number
    1719045-2014-10337
    Event Type
    Injury
    Date Received
    July 23, 2014
    Report Date
    June 26, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    PK011857
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. NO NONCONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 PRODUCT EVALUATION WAS PERFORMED. (B)(4). 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

    SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS.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

    (B)(4).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 A REVISION SURGERY DUE TO THE FEMORAL BLADE OF THE PATIENT'S TROCHANTERIC FIXATION NAIL GOING THROUGH THE ACETABULUM AND PAIN. THE PATIENT WAS ORIGINALLY TREATED FOR A HIP FRACTURE ON (B)(6) 2014. ON A UNKNOWN DATE, DURING A ROUTINE FOLLOW-UP, THE PATIENT COMPLAINED OF PAIN, THE EVENT WAS CONFIRMED VIA-X-RAYS. IT WAS NOTED THAT THE EVENT OCCURRED DUE TO THE BONE BEING "BAD". THE SURGEON REVISED THE PATIENT'S SURGERY TO A TOTAL HIP REPLACEMENT AND SURGERY WAS SUCCESSFULLY COMPLETED. THERE WERE NO OPERATIVE DELAYS REPORTED. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430953 12MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM ROD,FIXATION,INTRAMEDULLARY,SCREW,FIXATION,BONE HSB SYNTHES MONUMENT 7531820

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention