BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING CUDA, MICROBLADE, 2.0MM

    MDR report key: 1051228 · Received May 21, 2008

    Report

    Report Number
    1017294-2008-00200
    Event Type
    Malfunction
    Date Received
    May 21, 2008
    Date of Event
    April 22, 2008
    Report Date
    April 24, 2008
    Manufacturer
    CONMED LINVATEC
    Product Code
    HRX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION FINDINGS: CONMED LINVATEC REC'D THIS DEVICE FOR EVALUATION AND CONFIRMED THE REPORTED PROBLEM THAT THE TIP OF THE INNER TUBE BROKE AND DETACHED. FURTHER INVESTIGATION FOUND THAT THE TIP BROKE AT THE END OF THE EDM CUT AND NOT AT THE WELD. BASED ON THE ABOVE FACTS ALONG WITH THE EVIDENCE THAT THE OUTER TUBE WINDOW SHOWS SEVERE DAMAGE TO THE TEETH, THIS TYPE OF FAILURE COULD HAVE OCCURRED IF EXCESSIVE LATERAL FORCE WAS APPLIED DURING USE OR IF DURING USE THE TIP CAME IN CONTACT WITH AN OBJECT HARDER THAN ITSELF. A REVIEW OF PRODUCT HISTORY FOR THE PAST 2 YEARS FOUND 2 SIMILAR EVENTS WHERE THE TIP BROKE; HOWEVER, IN THESE TWO CASES, THE TIP WAS RETRIEVED. CONMED LINVATEC WILL CONTINUE TO TREND THIS FAILURE MODE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING USE OF THIS SHAVER BLADE IN AN ANKLE ARTHROSCOPY, THE TIP OF THE DEVICE BROKE OFF AND REMAINS IN THE PT'S CAVITY. TO DATE, THE PT IS GOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERLING CUDA, MICROBLADE, 2.0MM ARTHROSCOPY BLADE HRX CONMED LINVATEC NA BBD12727

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other