BEUDAMED
    FDA Adverse Event Injury Summary report: N

    10MM TI CANN TIBIAL NAIL-EX W/PROX BEND 360MM-STERILE

    MDR report key: 4221477 · Received November 3, 2014

    Report

    Report Number
    3000270450-2014-10139
    Event Type
    Injury
    Date Received
    November 3, 2014
    Report Date
    October 6, 2014
    Manufacturer
    SYNTHES SELZACH
    Product Code
    JDS
    PMA / PMN Number
    PK040762
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DATE: UNKNOWN. IMPLANT: EXACT DATE UNKNOWN; REPORTED AS APPROXIMATELY 7 MONTHS PRIOR TO EXPLANT ON (B)(6) 2014. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED: THE COMPLAINT WAS ASSESSED AS NOT RELATED TO STERILIZATION. A REVIEW OF DEPUY SYNTHES (B)(4) 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 PROXIMAL THIRD TIBIAL REVISION SURGERY WAS PERFORMED ON (B)(6) 2014 AFTER THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH COMPLAINTS OF PAIN. THE TIBIAL NAIL WAS BROKE AT THE ORIGINAL FRACTURE SITE, ALL SCREWS WERE INTACT. THE NAIL BROKE AT A SCREW HOLE BUT NO SCREW WAS IN THE HOLE. FOUR OF THE SCREWS WERE STANDARD LOCKING SCREWS OF WHICH THREE WERE POLLER SCREWS AND NOT USED IN THE NAIL. IT WAS REPORTED THERE WAS A NON-UNION AT THE ORIGINAL FRACTURE SITE; THE SCREWS WERE PROXIMAL TO THE NON-UNION SITE. DURING THE REVISION SURGERY THE SURGEON REMOVED ALL HARDWARE WHICH INCLUDED THE BROKEN NAIL AND SIX INTACT SCREWS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THE ORIGINAL SURGERY WAS PERFORMED STATUS POST A MOTOR VEHICLE ACCIDENT; THE ACTUAL SURGERY DATE IS UNKNOWN BUT REPORTED AS APPROXIMATELY SEVEN MONTHS AGO. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701999 10MM TI CANN TIBIAL NAIL-EX W/PROX BEND 360MM-STERILE NAIL,FIXATION,BONE JDS SYNTHES SELZACH 7368769

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention