BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAIL HOLDING SCREW, TIBIA T2 TIBIA 10 MM

    MDR report key: 2945740 · Received January 4, 2013

    Report

    Report Number
    9610622-2013-90005
    Event Type
    Malfunction
    Date Received
    January 4, 2013
    Date of Event
    December 14, 2012
    Report Date
    December 14, 2012
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT. ADDITIONAL DEVICE: 1806-1002 NAIL HANDLE T2 TIBIA LOT #UNK.

    Description of Event or Problem · 1

    DURING T2 TIBIA NAIL SURGERY, IT WAS CONFIRMED THAT THE NAIL HOLDING SCREW COULD NOT BE INSERTED TO THE NAIL HANDLE. IT BECAME IMPOSSIBLE TO CONTINUE THE SURGERY. OTHER INSTRUMENT SET WAS ARRANGED AND THE SURGERY WAS RESUMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5655 NAIL HOLDING SCREW, TIBIA T2 TIBIA 10 MM INSTRUMENT LXH STRYKER OSTEOSYNTHESIS KIEL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other