BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 3870787 · Received June 12, 2014

    Report

    Report Number
    0001056128-2014-00072
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Date of Event
    May 15, 2014
    Report Date
    May 19, 2014
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS LAKELAND
    Product Code
    HRX
    PMA / PMN Number
    K012635
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS RETURNED TO STRYKER SUSTAINABILITY SOLUTIONS (SSS) FOR AN EVALUATION. VISUAL INSPECTION REVEALED BIOLOGICAL MATERIAL ON THE DISTAL TIP OF THE DEVICE, INDICATING THE DEVICE WAS USED CLINICALLY. THE DISTAL TIP OF THE INNER SHAFT WAS OBSERVED TO BE BROKEN AND DETACHED. THE DISTAL TIP OF THE INNER SHAFT WAS NOT RETURNED FOR EVALUATION. GALLING WAS OBSERVED ON THE INSIDE THE DISTAL TIP OF THE OUTER SHAFT. THE RESULTS OF THE INVESTIGATION PERFORMED INDICATED THAT THE RETURNED DEVICE WAS OBSERVED TO HAVE A BROKEN/DETACHED DISTAL TIP ON THE INNER SHAFT, SUBSTANTIATING THE FACILITY¿S REPORTED ISSUE. BASED ON THE DAMAGE ON THE DISTAL TIPS, AND THE GALLING INSIDE THE DISTAL TIP OF THE OUTER SHAFT, THE MOST LIKELY CAUSES FOR THE REPORTED ISSUE WERE DETERMINED TO BE: 1) THE ARTHROSCOPIC SHAVER MAY HAVE COME INTO CONTACT WITH STAPLES, CLIPS OR ANOTHER METAL OBJECT, RESULTING IN DAMAGE TO THE BLADE; AND/OR 2) EXCESSIVE LATERAL FORCES EXERTED ON THE DEVICE DURING CLINICAL USE MAY HAVE CAUSED THE TEETH OF THE INNER SHAFT TO CONTACT THE CUTTING EDGES OF THE OUTER SHAFT, CAUSING THE TEETH TO CATCH ON THE OUTER SHAFT AS THE DEVICE ROTATED, AND THE OBSERVED GALLING AND DAMAGE TO THE DEVICE. THE INSTRUCTIONS FOR USE (IFU) FOR ARTHROSCOPIC SHAVERS (AS) STATES THE FOLLOWING: "DO NOT ALLOW THE ARTHROSCOPIC SHAVER TO COME INTO CONTACT WITH STAPLES, CLIPS OR ANY METAL OBJECT TO AVOID DAMAGE TO THE BLADE AND POSSIBLE PATIENT INJURY." "CAREFUL HANDLING OF THE INSTRUMENT IS NECESSARY TO AVOID DAMAGE OR BREAKAGE AS A RESULT OF EXCESSIVE FORCE." "DO NOT APPLY EXCESSIVE PRESSURE OR ¿SIDE-LOAD¿ THE BLADE DURING USE. SIDE-LOADING DOES NOT IMPROVE THE PERFORMANCE OF THE INSTRUMENT, CAN DULL THE BLADE, AND/OR PRODUCE METAL PARTICULATES." PRODUCT SURVEILLANCE WILL CONTINUE TO MONITOR COMPLAINTS OF THIS TYPE FOR ADVERSE TRENDS. THIS REPORT IS BEING FILED AS A MALFUNCTION DUE TO SSS BEING IN A 2 YEAR REPORTING CYCLE DUE TO MDR 0001056128-2014-00007 FILED ON (B)(4) 2014 WHERE TIP BROKE OFF AND PROCEDURE WENT FROM ARTHROSCOPIC TO OPEN IN ORDER TO REMOVE THE TIP. THE REPORTED EVENT IS NOT OCCURRING MORE FREQUENTLY OR WITH GREATER SEVERITY THAN IS USUAL FOR THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "DURING SURGERY, A PIECE OF THE SHAVER BROKE OFF AND WAS RETRIEVED." THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO MEDICAL TREATMENT OR INTERVENTION REQUIRED AND NO ADVERSE CONSEQUENCES ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347625 NA ARTHROSCOPE HRX STRYKER SUSTAINABILITY SOLUTIONS LAKELAND 375-545-000 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1