BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION,BONE

    MDR report key: 3871153 · Received June 13, 2014

    Report

    Report Number
    2520274-2014-11836
    Event Type
    Injury
    Date Received
    June 13, 2014
    Report Date
    May 16, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). DATE OF EVENT: UNKNOWN. THIS REPORT IS FOR 1 UNKNOWN SCREW/UNKNOWN LOT. PARTIAL PART NUMBER OF 02.205.XXX WAS PROVIDED. 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. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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 THAT A FOLLOW-UP ON A PATIENT POST-OPERATIVELY FOR AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF A LEFT PROXIMAL FEMUR, REVEALED A NONUNION OF THE FEMUR AND A BROKEN CONSTRUCT. THE DECISION WAS MADE TO REVISE THE CONSTRUCT. THE HARDWARE WAS REMOVED. UPON REMOVAL, TWO SCREWS WERE FOUND TO BE BROKEN. ALL BROKEN FRAGMENTS WERE REMOVED AND THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATION. THIS REPORT IS FOR ONE UNKNOWN SCREW. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351293 SCREW, FIXATION,BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention