BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE-THIRD TUBULAR PLATE 4 HOLES/49MM

    MDR report key: 3223415 · Received July 12, 2013

    Report

    Report Number
    2520274-2013-04197
    Event Type
    Injury
    Date Received
    July 12, 2013
    Report Date
    June 18, 2013
    Manufacturer
    SYNTHES (USA)
    Product Code
    HRS
    PMA / PMN Number
    PREAMEND
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACTUAL EVENT DATE NOT KNOWN. IMPLANT ON AN UNKNOWN DATE IN THE EARLY 1990S. THE LOT NUMBER PROVIDED DOES NOT APPEAR TO BE ACCURATE AND IS NOT RECOGNIZED. WITHOUT A RECOGNIZABLE 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT SUSTAINED AN ANKLE FRACTURE ON AN UNKNOWN DATE. THE PATIENT WAS IMPLANTED WITH ONE-THIRD TUBULAR PLATE, K-WIRES AND SCREWS ON AN UNKNOWN DATE IN THE EARLY 1990S. A SYNDESMOTIC SCREW WAS PLACED IN THE ANKLE AND A POST-OPERATIVE X-RAY TAKEN ON AN UNSPECIFIED DATE REVEALED A HEALED FRACTURE BUT THE SYNDESMOTIC SCREW HAD BROKEN. REPORTEDLY THE PATIENT COMPLAINED OF PAIN. THE PATIENT WAS RETURNED TO THE O.R. ON (B)(6) 2013 FOR REMOVAL OF ALL HARDWARE. THE SURGEON REMOVED ALL HARDWARE EXCEPT FOR THE BROKEN FRAGMENT OF THE CANCELLOUS SCREW IN THE TIBIA. IT WAS REPORTED IT WAS DEEMED TOO INVASIVE TO ATTEMPT REMOVAL OF THE SYNDESMOTIC SCREW. THE IMPLANTS WERE REPORTEDLY REMOVED SUCCESSFULLY. THE HOSPITAL REPRESENTATIVE CERTIFIED THAT ALL THE INFORMATION AVAILABLE TO SYNTHES WAS PROVIDED AND THE HARDWARE WILL NOT BE RETURNED FOR EVALUATION. THE PART AND LOT NUMBERS OF THE SCREWS ARE UNKNOWN. THE DATE OF EVENT IS ALSO UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 5 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322743 ONE-THIRD TUBULAR PLATE 4 HOLES/49MM HRS SYNTHES (USA) 80220

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention