BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIBIAL NAIL, LEFT

    MDR report key: 4142154 · Received October 5, 2014

    Report

    Report Number
    2520274-2014-13914
    Event Type
    Injury
    Date Received
    October 5, 2014
    Report Date
    September 9, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    JDS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR ONE UNKNOWN PART/NAIL/UNKNOWN LOT NUMBER. IMPLANT DATE UNKNOWN. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORD REVIEW AND 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 COMPLETE DESCRIPTION OF THE BRAND NAME IS UNKNOWN, AS THE PART NUMBER IS NOT AVAILABLE. A PARTIAL DESCRIPTION OF THE BRAND NAME HAS BEEN ADDED.(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

    TO DATE, REVISION SURGERY HAS NOT BEEN RESCHEDULED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MALE PATIENT UNDERWENT A PLANNED REVISION FOR A NON-UNION. SURGERY WAS PERFORMED ON (B)(6) 2014 FOR A LEFT TIBIAL NAIL EXCHANGE. ONE ANTEROPOSTERIOR 5.0 MILLIMETER LOCKING SCREW WAS REMOVED. SUBSEQUENTLY, A LIGHT HANDLE FELL AND CONTAMINATED THE SURGICAL FIELD. THE SURGICAL SITE WAS CLOSED. THE PATIENT WILL RETURN TO SURGERY AT A LATER DATE FOR REMOVAL OF REMAINING HARDWARE: THREE SCREWS, ONE ENDCAP AND ONE NAIL. THIS REPORT IS 3 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621804 TIBIAL NAIL, LEFT NAIL, FIXATION, BONE JDS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention