BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    K-WIRE, RECON 3.2X400 MM

    MDR report key: 2234700 · Received July 21, 2011

    Report

    Report Number
    9610622-2011-00323
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    June 27, 2011
    Report Date
    June 28, 2011
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    LXH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: EVAL REVEALED THAT THE FOUND BROKEN K-WIRE TIP IS LINKED TO THE DESIGN OF THE DEVICE. A DESIGN CHANGE WAS PERFORMED TO OPTIMIZE THE K-WIRE TIP REDUCING THE RISK OF TIP BREAKAGES. THE RETURNED K-WIRE WAS IDENTIFIED AS OLD DESIGN VERSION. DEVIATIONS IN THE MFG AND INSPECTION DOCUMENTS WERE NOT FOUND. THE FUNCTION WAS GIVEN IN FULL ON THE DEVICE AT THE STAGE OF DELIVERY.

    Description of Event or Problem · 1

    DURING THE T2 RECON NAIL SURGERY, THE SURGEON INSERTED THE K-WIRE FOR THE LAG SCREW HOLE DRILLING. HOWEVER, THE TIP OF K-WIRE BROKE. THE BROKEN PIECE REMAINED IN THE FEMORAL BONE. AFTERWARDS, THE SURGEON INSERTED NEW K-WIRE, AND DID THE DRILLING. THE SURGEON REMOVED THE BROKEN PIECE OF K-WIRE FROM THE LAG SCREW HOLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 K-WIRE, RECON 3.2X400 MM INSTRUMENT LXH STRYKER OSTEOSYNTHESIS KIEL NA K906373

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other