BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 3933076 · Received July 14, 2014

    Report

    Report Number
    2520274-2014-12560
    Event Type
    Injury
    Date Received
    July 14, 2014
    Report Date
    June 16, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR ONE UNKNOWN 3.0 MM HEADLESS COMPRESSION SCREW. IMPLANT DATE: REPORTED AS AN UNKNOWN DATE ABOUT A YEAR AGO. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. 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 A REVISION SURGERY DUE TO A BROKEN LOCKING COMPRESSION POSTEROLATERAL PLATE AND A BROKEN SCREW. THE PATIENT WAS ORIGINALLY TREATED FOR A DISTAL HUMERUS FRACTURE. ON AN UNKNOWN DATE, THE PATIENT PRESENTED WITH PAIN AND IT WAS CONFIRMED VIA X-RAY THE PATIENT HAD A BROKEN PLATE AND BROKEN SCREW. THE PLATE WAS BROKEN DISTALLY AND THE 3.0 MM HEADLESS COMPRESSION SCREW (LAG SCREW) WAS BROKEN, WHICH WAS OUTSIDE THE PLATE. THE SURGEON EXPLANTED ALL HARDWARE WHICH INCLUDED ONE LOCKING COMPRESSION PLATE AND SIX SCREWS. OF THE SIX SCREWS, THREE WERE PROXIMAL SCREWS, AND THREE WERE DISTAL SCREWS (ONE BEING THE HEADLESS COMPRESSION SCREW LOCATED OUTSIDE OF THE PLATE). THE FIVE SCREWS IN THE PLATE WERE A COMBINATION OF UNKNOWN 3.5 MM LOCKING SCREWS AND UNKNOWN 2.7 MM LOCKING SCREWS. ALL HARDWARE WAS REMOVED EASILY WITHOUT ADDITIONAL MEDICAL INTERVENTION. THE SURGEON RE-PLATED THE PATIENT AND SURGERY WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE UNKNOWN 3.0 MM HEADLESS COMPRESSION SCREW THIS REPORT IS 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411093 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention