BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 3073295 · Received April 23, 2013

    Report

    Report Number
    0001056128-2013-00047
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    March 29, 2013
    Report Date
    March 29, 2013
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS LAKELAND
    Product Code
    HRX
    PMA / PMN Number
    K012605
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UPDATED DUE TO A TYPO.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS RETURNED TO STRYKER SUSTAINABILITY SOLUTIONS (SSS) FOR AN EVALUATION. A VISUAL EXAMINATION OF THE COMPLAINT DEVICE REVEALED THE DISTAL TIP OF THE INNER SHAFT WAS BROKEN AND DETACHED. EVALUATION OF THE DISTAL TIP OF THE INNER SHAFT REVEALED THE CUTTING EDGE TEETH TO BE BENT AND DAMAGED. GALLING WAS OBSERVED ON THE INSIDE OF THE DISTAL TIP OF THE OUTER SHAFT. BASED ON THE OBSERVED DAMAGE, POTENTIAL CAUSES WERE DETERMINED TO BE THAT THE DEVICE MAY HAVE COME INTO CONTACT WITH STAPLES, CLIPS OR ANOTHER METAL OBJECT, RESULTING IN DAMAGE TO THE BLADE; OR EXCESSIVE LATERAL FORCES WERE EXERTED ON THE DEVICE DURING CLINICAL USE WHICH 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. STRYKER SUSTAINABILITY SOLUTIONS' INSTRUCTIONS FOR USE STATES: "DO NOT ALLOW THE ARTHROSCOPIC SHAVER TO COME IN 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." THIS REPORT IS BEING FILED AS A MALFUNCTION DUE TO SSS BEING IN A 2 YEAR REPORTING CYCLE DUE TO MDR REPORT 1056128-2011-00065 WHERE AN ADDITIONAL INCISION WAS NEEDED TO REMOVE THE TIP OF THE DEVICE THAT HAD BROKEN OFF IN THE PATIENT'S KNEE EVEN THOUGH THERE WAS NO PATIENT INJURY IN THIS EVENT. 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 A PROCEDURE "THE TIP BROKE OFF" OF THE ARTHROSCOPIC SHAVER. NO PATIENT INJURY WAS REPORTED BY THE USER FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE "THE TIP BROKE OFF" OF THE STEREOSCOPIC SHAVER. NO PATIENT INJURY WAS REPORTED BY THE USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174598 NA HRX HRX STRYKER SUSTAINABILITY SOLUTIONS LAKELAND 375-544-000 2288378

    Patients

    Seq Age Sex Outcome Treatment
    1