BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHONDRAL PICKS:SM SHAFT ASSY:40 DEG

    MDR report key: 1060546 · Received June 12, 2008

    Report

    Report Number
    1219602-2008-00147
    Event Type
    Malfunction
    Date Received
    June 12, 2008
    Report Date
    May 14, 2008
    Manufacturer
    SMITH & NEPHEW INC., ENDOSCOPY DIV.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT APPEARS THAT THE DEVICE MAY HAVE GOTTEN CAUGHT UP IN THE BONEY STRUCTURE OF THE TALUS AND COULD NOT EASILY BE REMOVED, RESULTING IN THE TIP BREAKING. NO OTHER COMPLAINTS ARE ON FILE FOR THIS LOT.

    Description of Event or Problem · 1

    PICK SNAPPED OFF DURING MICROFRACTURE OF THE TALUS. THE WOUND WAS EXTENDED TO ENABLE RETRIEVAL. A ONE HOUR DELAY RESULTED AND A BACK-UP DEVICE WAS AVAILABLE. NO PATIENT INJURY OR COMPLICATION TOOK PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHONDRAL PICKS:SM SHAFT ASSY:40 DEG CHONDRAL PICK LXH SMITH & NEPHEW INC., ENDOSCOPY DIV. 014796 50219235

    Patients

    Seq Age Sex Outcome Treatment
    1 NA