BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW,FIXATION,BONE

    MDR report key: 3900519 · Received June 27, 2014

    Report

    Report Number
    2520274-2014-12215
    Event Type
    Injury
    Date Received
    June 27, 2014
    Report Date
    June 2, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR THREE UNKNOWN SCREWS/UNKNOWN LOT. DATE OF IMPLANT: (B)(6) 2013, EXACT DATE UNKNOWN. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. NO ISSUES WERE FOUND DURING MANUFACTURE THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. 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 DURING THE REVISION THE INSTRUMENT HANDLE SPLIT. THE ORIGINAL PROCEDURE WAS A TIBIAL NAILING FROM (B)(6) 2013. THE REVISION WAS DUE TO A NON-UNION. THE DEVICE WAS USED WITH NO IMPACT ON THE CASE. THE TIBIAL NAIL AND THREE SCREWS WERE ALL REMOVED FULLY INTACT. THIS REPORT IS FOR THREE UNKNOWN SCREWS. THIS IS REPORT 3 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377664 SCREW,FIXATION,BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention