BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 3881515 · Received June 18, 2014

    Report

    Report Number
    2520274-2014-11983
    Event Type
    Injury
    Date Received
    June 18, 2014
    Report Date
    May 22, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL DEVICE INFO: THIS REPORT IS FOR THE LOCKING SCREWS, 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

    THE SURGEON WAS REMOVING AN UNKNOWN SIZE VARIABLE ANGLE LOCKING COMPRESSION PLATE MEDIAL DISTAL TIBIA PLATE DUE TO A NON-UNION. WHILE REMOVING, IT WAS REALIZED THE HEADS OF ALL THE 2.7 VA LOCKING SCREWS WERE BROKEN OFF, UNKNOWN PART NUMBERS AND QUANTITY, THE SCREWS WERE REPORTED TO BE BROKEN PRIOR TO REMOVAL. THE DEVICES WERE IMPLANTED AT A DIFFERENT HOSPITAL ON AN UNKNOWN DATE THE PARTS ARE UNAVAILABLE, AS THEY WERE DISCARDED. ALL DEVICES WERE REMOVED SUCCESSFULLY FROM THE PATIENT AND NO FRAGMENTS WERE LEFT BEHIND. PROCEDURE WAS COMPLETED SUCCESSFULLY, THE X-RAYS ARE UNAVAILABLE. THERE WAS A FIVE MINUTE DELAY DUE TO THE REPORTED EVENT. THIS REPORT IS FOR THE LOCKING SCREWS, 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
    357446 SCREW, FIXATION, BONE HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention