BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.0MM TI LOCKING SCREW W/T25 STARDRIVE 36MM FOR IM NAILS

    MDR report key: 6679429 · Received June 29, 2017

    Report

    Report Number
    1719045-2017-10615
    Event Type
    Injury
    Date Received
    June 29, 2017
    Report Date
    June 5, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HWC
    PMA / PMN Number
    K000089
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF DEVICE BREAKAGE AND NON-UNION IS NOT KNOWN. (B)(4). DATE OF IMPLANT REPORTED AS APPROXIMATELY 9 MONTHS PRIOR TO EXPLANT. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. CONCOMITANT DEVICES THERAPY DATE REPORTED AS APPROXIMATELY 9 MONTHS PRIOR TO EXPLANT. 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 REPORT THAT THE PATIENT HAD ORIGINAL SURGERY ON (B)(6) 2016 FOR TREATMENT OF A RIGHT TIBIA FRACTURE. PATIENT WAS IMPLANTED WITH ONE (1) TITANIUM CANNULATED EX TIBIAL NAIL, THREE (3) 5.0MM LOCKING SCREWS AND ONE (1) TIBIAL NAIL END CAP. ON AN UNKNOWN DATE, POST-OPERATIVELY, PATIENT PRESENTED WITH A BROKEN SCREW IMPLANT AND A NON-UNION. ON (B)(6), 2017 SURGEON REMOVED ALL IMPLANTS AND REVISED THE PATIENT TO A NEW TIBIA NAIL CONSTRUCT. DURING THE REVISION PROCEDURE, SURGEON HAD DIFFICULTY REMOVING THE BROKEN SCREW. FRAGMENTS WERE GENERATED DURING THE IMPLANT REMOVAL AND WERE HARD TO RETRIEVE. DUE TO THIS EVENT AN ADDITIONAL 10-15 MINUTES WAS ADDED TO OPERATING ROOM TIME. SURGEON USED FORCEPS TO REMOVE THE BROKEN SCREW IMPLANT AND FRAGMENTS. PATIENT WAS REPORTED IN STABLE CONDITION AND REVISION SURGERY WAS COMPLETED SUCCESSFULLY. REMOVAL OF BROKEN SCREW IS ADDRESSED IN COM-(B)(4). THIS REPORT ADDRESSES THE REVISION SURGERY. CONCOMITANT DEVICES REPORTED: 11MM TI CANN TIBIAL NAIL-EX W/PROX BEND 375MM-STERILE (PART NUMBER 04.034.555S, LOT NUMBER 9830042, QUANTITY 1); 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 44MM FOR IM NAILS (PART NUMBER 04.005.534, LOT NUMBER UNKNOWN, QUANTITY 1); 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 50MM FOR IM NAILS (PART NUMBER 04.005.540, LOT NUMBER UNKNOWN, QUANTITY 1); TI END CAP WITH T40 STARDRIVE 0MM EXT F/TI TIBIAL NAILS-EX (PART NUMBER 04.004.000, LOT NUMBER UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 5.0MM LOCKING SCREW. THIS IS REPORT 1 OF 1 FOR COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457009 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 36MM FOR IM NAILS SCREW,FIXATION,BONE HWC SYNTHES MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention