BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    K-WIRE, RECON 3.2X400 MM

    MDR report key: 2471480 · Received February 13, 2012

    Report

    Report Number
    9610622-2012-00072
    Event Type
    Malfunction
    Date Received
    February 13, 2012
    Date of Event
    January 24, 2012
    Report Date
    January 25, 2012
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    LXH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED FOR EVALUATION. IF ADDITIONAL INFO IS RECEIVED IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    WHILE TRYING TO INSERT THE K-WIRE RECON (ITEM 18063030S) (LOT K291398) THROUGH THE NAIL, THE WIRE SKYVED AND LODGED IN THE NAIL. IT APPEARED THAT THE JIG MAY HAVE DISTORTED SLIGHTLY AS THE REGIE WAS 'RIDING' THE JIG. THE TIP OF THE WIRE BROKE OFF AND WAS LODGED IN THE NAIL. IT WAS NOT POSSIBLE TO INSERT THE SOLID LAG SCREW STEP DRILL INTO THE NAIL, AS THE BROKEN WIRE TIP WAS IMPEDING THE ENTRY. MULTIPLE ADDITIONAL INSTRUMENTS WERE OPENED TO TRY AND DISLODGE THE WIRE TIP; BUT TO NO AVAIL. INCREASE TO OPERATING TIME OF ABOUT 40 MINUTES. THE REGIE THEN TRIED TO INSERT THE SOLID 52 RECON SOLID LAG SCREW STEP DRILL AND THIS TIME IT PASSED THROUGH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 K-WIRE, RECON 3.2X400 MM INSTRUMENT LXH STRYKER OSTEOSYNTHESIS KIEL NA K291398

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other