BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WASHER 13.0MM

    MDR report key: 3192273 · Received June 27, 2013

    Report

    Report Number
    2520274-2013-03797
    Event Type
    Injury
    Date Received
    June 27, 2013
    Report Date
    May 30, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HTN
    PMA / PMN Number
    PREAMEND
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. MANUFACTURING RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER.

    Description of Event or Problem · 1

    A PATIENT, IMPLANTED DURING A CALCANEAL PROCEDURE ON (B)(6) 2013 RETURNED TO SURGEON COMPLAINING OF PAIN. FOLLOW-UP X-RAYS SHOWED INCREASED DISPLACEMENT OF THE CALCANEAL BONE. DURING THE REVISION SURGERY WHILE SURGEON WAS IMPLANTING THE TOP RIGHT LOCKING SCREW INTO THE VA LOCKING X PLATE, THE LOCKING SCREW WENT THRU THE PLATE. ALSO, WHILE IMPLANTING THE LOCKING SCREW INTO THE BOTTOM LEFT SCREW HOLE OF THE X-PLATE THE SCREW WOULD NOT LOCK. THE SURGEON HAD NO ISSUES WITH IMPLANTING THE TOP LEFT AND BOTTOM RIGHT SCREWS. SURGEON THEN REMOVED THE TOP RIGHT AND THE TOP LEFT SCREWS AND REPLACED THEM WITH CORTICAL SCREWS. SURGEON DID NOT LIKE THE POSITION OF THE SCREWS AND PLATE. HE NOTED ON X-RAY THAT THE SCREWS WERE IN A PROMINENT POSITION ABOVE THE PLATE AND SCREWS DID NOT SIT FLUSH WITH THE PLATE. SURGEON REMOVED THE 2 SCREWS AND DETERMINED THAT THE HOLES IN THE BONE WERE NOW TOO BIG FOR HIM TO REINSERT 2.4MM LOCKING SCREWS. AGAIN SURGEON TOOK X-RAYS AND DETERMINED THAT THE VA X-PLATE AND SCREW CONSTRUCT WAS NOT HELPING THE PATIENT. SURGEON REMOVED THE VA X-PLATE AND SCREW CONSTRUCT AND REVISED PATIENT TO 2 4.5MM CORTEX SCREWS AND 2 13.0MM WASHERS. ALSO, WHILE THE SURGEON WAS USING THE 1.2MM TORQUE LIMITING ATTACHMENT TO INSERT THE CORTEX SCREW INTO THE TOP LEFT SCREW POSITION THE INSTRUMENT FELL APART. THE SPRING SHOT ACROSS THE ROOM AND THE TWO OTHER PIECES OF THE INSTRUMENT WERE FOUND IN THE STERILE FIELD. SURGEON CHOSE ANOTHER SCREWDRIVER TO COMPLETE THE SURGERY. DUE TO THESE EVENTS AN ADDITIONAL 1 HOUR AND 45 MINUTES WERE ADDED TO SURGERY TIME. THIS REPORT IS 1 OF 10 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294299 WASHER 13.0MM HTN SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention