BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 3924435 · Received July 9, 2014

    Report

    Report Number
    2520274-2014-12482
    Event Type
    Injury
    Date Received
    July 9, 2014
    Report Date
    June 11, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR ONE UNKNOWN 5.0 LOCKING SCREW/UNKNOWN LOT. DEVICE HAS NOT BEEN EXPLANTED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 PATIENT HAS A NON-UNION OF A TROCHANTERIC HIP FRACTURE ON AN UNKNOWN DATE THAT WAS TREATED WITH A TROCHANTERIC FIXATION NAIL (TFN) ON (B)(6) 2014. ADDITIONALLY, THE HELICAL BLADE IS CUTTING OUT OF THE FEMORAL HEAD SUPERIORLY, THERE WAS ONE 5.0 LOCKING SCREW USED THROUGH THE NAIL. THE SURGEON HAS NOT SCHEDULED A REVISION SURGERY OR EXPLANATION AT THIS TIME. THIS REPORT IS FOR ONE UNKNOWN 5.0 LOCKING SCREW. THIS IS REPORT 2 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401049 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention