BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 2221803 · Received August 24, 2011

    Report

    Report Number
    1056128-2011-00084
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    July 27, 2011
    Report Date
    July 29, 2011
    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

    A VISUAL EXAMINATION OF THE COMPLAINT DEVICE REVEALED THE DISTAL TIP OF THE INNER SHAFT WAS BROKEN OFF. THE TIP WAS NOT RETURNED FOR EVALUATION. DAMAGE WAS ALSO OBSERVED ON THE CUTTING EDGE TIP OF THE OUTER SHAFT. THE DEVICE PASSED ROLL TESTING AND DROP TESTING CONFIRMING THE DEVICE WAS NOT BENT. BASED ON THE OBSERVED DAMAGE, THE MOST PROBABLE CAUSE OF THE BROKEN TIP WAS DETERMINED TO BE THAT THE DEVICE MADE IMPACT WITH A HARD OBJECT DURING CLINICAL USE OR EXCESSIVE LATERAL FORCES WERE EXERTED ON THE DEVICE DURING CLINICAL USE WHICH CAUSED THE DEVICE TO BREAK. 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. 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 WHEN THE ARTHROSCOPIC CUTTER WAS REMOVED FROM THE PATIENT, THE END OF THE CUTTER WAS BROKEN BUT STILL ATTACHED TO THE DEVICE. NOTHING FELL INTO THE PATIENT AND NO PATIENT INJURY WAS REPORTED BY THE USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 N/A HRX HRX STRYKER SUSTAINABILITY SOLUTIONS 375-544-000 1572279

    Patients

    Seq Age Sex Outcome Treatment
    1