BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 2502237 · Received March 23, 2012

    Report

    Report Number
    1056128-2012-00030
    Event Type
    Malfunction
    Date Received
    March 23, 2012
    Date of Event
    February 27, 2012
    Report Date
    February 27, 2012
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS
    Product Code
    HRX
    PMA / PMN Number
    K012605
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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 OFF. THE CUTTING EDGE TEETH WERE BENT AND DAMAGED. THE CUTTING EDGES OF THE OUTER SHAFT WERE ALSO DAMAGED AND GALLING WAS OBSERVED INSIDE THE OUTER SHAFT. BASED ON THE OBSERVED DAMAGE, POTENTIAL CAUSES OF THE BROKEN TIP 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 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. 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." THE DEVICE HISTORY RECORD FOR THE RETURNED DEVICE INDICATES THAT THE CUTTER PASSED ALL APPLICABLE INSPECTIONS AND TESTS PRIOR TO RELEASE. THIS REPORT IS BEING FILED AS A MALFUNCTION DUE TO SSS BEING IN A 2 YEAR REPORTING CYCLE DUE TO MDR REPORT 1056128-2010-00065 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 AN ARTHROSCOPIC KNEE PROCEDURE, THE TIP OF THE ARTHROSCOPIC CUTTER BROKE OFF OF THE DEVICE ON THE STERILE FILED OUTSIDE OF THE PATIENT. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 N/A HRX HRX STRYKER SUSTAINABILITY SOLUTIONS 375-544-000

    Patients

    Seq Age Sex Outcome Treatment
    1