BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 4133274 · Received October 1, 2014

    Report

    Report Number
    2520274-2014-13865
    Event Type
    Injury
    Date Received
    October 1, 2014
    Report Date
    September 5, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. THIS REPORT IS FOR FOUR UNKNOWN CORTEX SCREWS. 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 PATIENT RETURNED TO THE CLINIC FOR FOLLOW UP STATUS POST OPEN REDUCTION INTERNAL FIXATION (ORIF) DISTAL TIBIA AND POPLITEAL-POSTERIOR TIBIAL BYPASS GRAFT DUE TO GUNSHOT WOUND. FINDINGS SHOWED MODERATE SWELLING, BROKEN HARDWARE, DELAYED HEALING AND NON-UNION. THE SURGEON DISCUSSED WITH PATIENT THAT EARLY WEIGHT BEARING MAY CAUSE HARDWARE FAILURE. ON (B)(6) 2014, THE PATIENT WAS REVISED TO AN ORIF DISTAL TIBIA WITH ANTERIOR LATERAL PLATE AND BONE GRAFT. THE PATIENT RECEIVED BONE GRAFT IN ADDITION TO NEW HARDWARE AND DUE TO PATIENT HAVING AN OPEN FRACTURE DURING THE ORIGINAL SURGERY; THE PATIENT WAS UNABLE TO RECEIVE BONE GRAFTING IN FIRST PLACE. A 3.5 MM LCP LOW BEND MEDIAL DISTAL TIBIAL PLATE, LEFT WAS REMOVED. FOUR 3.5 MM CORTEX SCREW HEADS AND FOUR 3.5 MM LOCKING SCREW HEADS WERE REMOVED HOWEVER THEIR SHAFTS REMAINED IN THE PATIENT. FOUR COMPLETE 3.5 MM LOCKING SCREWS WERE REMOVED. THE SURGEON DID NOT WANT TO RETRIEVE REMAINING SCREW PIECES FROM THE BONE. PATIENT OUTCOME IS FINE AND THERE WAS NO SURGICAL DELAY. REVISION PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR FOUR UNKNOWN CORTEX SCREWS. THIS REPORT IS 2 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610830 SCREW, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Required Intervention