BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW

    MDR report key: 2882367 · Received December 20, 2012

    Report

    Report Number
    2520274-2012-04243
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Report Date
    November 21, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. 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.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM (B)(4) INDICATED A HOSPITAL IN (B)(6) REPORTED. HOSPITAL FACILITY WASHED UNKNOWN SCREWS AND NOTICED SMALL WHITE PARTICLE REMNANTS AROUND THE NECK OF THE SCREW. THEY RAN THE SCREWS THROUGH THE WASH A FURTHER TWO TIMES BUT WHERE STILL UNABLE TO REMOVE ALL OF THE FRAGMENTS. THE SCREWS WHERE WASHED IN THE SYNTHES SCREW CADDY. ANY REMAINING PARTICLES FOUND WHERE AT THE UPPER END OF THE SCREW SHAFT WHERE THE SCREW SITS INTO THE CADDY. THEY DO NOT BELIEVE THE PARTICLES ARE BONE OR DETERGENT. HOSPITAL CLEANED THE SCREWS AND WILL NOT BE RETURNING THEM TO SYNTHES. THIS IS 2 OF 4 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCREW HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1