BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONE SCREW VARIAX FULL THREAD 2.7MM / L22MM

    MDR report key: 3273683 · Received August 9, 2013

    Report

    Report Number
    0008031020-2013-00265
    Event Type
    Injury
    Date Received
    August 9, 2013
    Date of Event
    May 17, 2013
    Report Date
    July 15, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-SELZACH
    Product Code
    HRS
    PMA / PMN Number
    K101056
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    REPORTED VIA MAUDE EVENT REPORT, (B)(4), ORIGINALLY (B)(6) SUFFERED A MID-SHAFT HUMERUS FRACTURE IN A 4-WHEELER ACCIDENT ON (B)(6) 2013 AND WAS DEVELOPING WORSENING RADIAL NERVE PALSY IN THE ED. HE HAD ORIF AND RADIAL NERVE NEUROLYSIS URGENTLY WITH REMOVAL OF BONE FRAGMENTS FROM NERVE AND COLLAGEN PROTECTIVE WRAPPING OF THE NERVE. A STRYKER POSTEROLATERAL PLATE WHICH WAS SLIGHTLY CONTOURED WAS FIT ONTO THE BONE EXCELLENT FIT ACROSS THE FRACTURE. PLATE WAS SHORTENED APPROX 2 MM IN SITU WITH A MIDAS REX TOOL WITH THE CUTTING BUR AS IT WAS OVERLAPPING THE EDGE OF THE OLECRANON FOSSA. WRIST SUPPORTED WITH A COCK-UP WRIST SPLINT WHILE RADIAL NERVE RECOVERED. STARTED ON NEURONTIN, ENCOURAGED SMOKING CESSATION AND AGGRESSIVE EARLY ROM TO BOTH SHOULDER AND ELBOW WITH 1# LIFTING RESTRICTION. PT FELL ON (B)(6) 2013 AND FELT A SNAP IN HIS ARM WITH RADIOLOGICAL EVIDENCE OF HARDWARE FAILURE AND REFRACTURE. ARM PLACED IN A BRACE UNTIL ADMITTED ELECTIVELY (B)(6) 2013 FOR HARDWARE REMOVAL AND REFIXATION. AT THAT TIME, STATED HE QUIT SMOKING 3 WEEKS AGO. SURGEON VOICED HER OPINION THAT SHE DOESN'T BELIEVE THIS IS A PRODUCT FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377603 BONE SCREW VARIAX FULL THREAD 2.7MM / L22MM IMPLANT HRS STRYKER OSTEOSYNTHESIS-SELZACH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention