BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 3831543 · Received May 25, 2014

    Report

    Report Number
    2520274-2014-11589
    Event Type
    Malfunction
    Date Received
    May 25, 2014
    Date of Event
    April 30, 2010
    Report Date
    April 30, 2010
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR THE LOCKING SCREW(S), QUANTITY, PART AND LOT NUMBER UNKNOWN. 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. 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 THE PATIENT FELL DOWN THE STAIRS ON (B)(6) 2010 AND SUFFERED A SHATZKER FRACTURE. THE SURGEON ATTEMPTED TO IMPLANT A PLATE BUT WAS UNABLE TO DUE TO THE FIT OF THE LOCKING SCREWS BEING TOO DISTAL OF A FIT WITH THE RAFT JOINT. THE SURGEON PERFORMED THE FIXATION WITH A 1/3 TUBULAR PROXIMAL TO TIBIA PLATE IN ORDER TO SUPPORT THE ELEVATED JOINT AND GRAFT. THIS REPORT IS FOR THE LOCKING SCREW(S), QUANTITY, PART AND LOT NUMBER UNKNOWN. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309818 SCREW, FIXATION, BONE HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR