BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.0MM CANNULATED SCREW LONG THREAD/34MM

    MDR report key: 2968297 · Received February 19, 2013

    Report

    Report Number
    1719045-2013-00364
    Event Type
    Injury
    Date Received
    February 19, 2013
    Date of Event
    July 12, 2010
    Report Date
    July 12, 2010
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HWC
    PMA / PMN Number
    K951304
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    WITHOUT 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.

    Additional Manufacturer Narrative · 1

    CORRECTED AWARENESS DATE TO (B)(6) 2010.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: ADDITIONAL PRODUCT CODE FOR THIS REPORT INCLUDES HTN THE 510K # IS K951304. CORRECT PRODUCT CODE FOR THIS REPORT IS HWC.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING ARTHRODESIS RIGHT MIDDLE FINGER DIP JOINT, A SYNTHES CANNULATED SCREW STARTED TO BEND WITH INSERTION AND UPON RETRIEVAL IT BROKE. IN ORDER TO RETRIEVE THE SCREW, THE CORTEX HAD TO BE BREACHED THE ARTHRODESIS PROCEEDED WITH A 30 MM LONG THREAD 3-0 SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72242 3.0MM CANNULATED SCREW LONG THREAD/34MM HWC SYNTHES MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR