BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 6779176 · Received August 9, 2017

    Report

    Report Number
    0001056128-2017-00103
    Event Type
    Malfunction
    Date Received
    August 9, 2017
    Date of Event
    July 12, 2017
    Report Date
    August 9, 2017
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS LAKELAND
    Product Code
    HRX
    UDI-DI
    00885825014223
    PMA / PMN Number
    K012635
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO STRYKER SUSTAINABILITY SOLUTIONS FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED DEVICE REVEALED THE INNER AND OUTER SHAFTS DETACHED READILY; THERE WAS NO OBVIOUS BEND IN THE INNER SHAFT. NO GALLING WAS OBSERVED ALONG THE INSIDE DIAMETER OF THE OUTER SHAFT. THE INNER SHAFT TIP WAS BROKEN OFF AND SHOWED NO TOOTH DAMAGE. A REVIEW OF THE DHR FOR THE REPORTED LOT NUMBER SUPPORTS THAT THE DEVICE MET ALL INSPECTION AND TEST CRITERIA PRIOR TO RELEASE FROM STRYKER. THEREFORE, THE MOST LIKELY ROOT CAUSES ARE THE USER APPLIED TOO MUCH FORCE TO THE DEVICE OR THE ARTHROSCOPIC SHAVER MAY HAVE COME INTO CONTACT WITH STAPLES, CLIPS OR ANOTHER METAL OBJECT, RESULTING IN DAMAGE TO THE BLADE. THE INSTRUCTIONS FOR USE (IFU) STATE: -BEFORE BEGINNING THE PROCEDURE, VERIFY COMPATIBILITY OF ALL INSTRUMENTS AND ACCESSORIES. -PLUG IN AND SET UP THE GENERATOR ACCORDING TO THE INSTRUCTIONS IN THE MANUFACTURERS¿ MANUAL. -SELECT AN ARTHROSCOPIC SHAVER WITH SIZE, BLADE, AND FUNCTION MOST APPROPRIATE FOR THE PROCEDURE. -INSPECT THE INSTRUMENT FOR OVERALL CONDITION AND PHYSICAL INTEGRITY. DO NOT USE THE INSTRUMENT IF ANY DAMAGE IS NOTED. RETURN THE INSTRUMENT AND PACKAGING TO STRYKER SUSTAINABILITY SOLUTIONS IF IT IS NOT IN ACCEPTABLE CONDITION FOR SURGERY. -FOLLOW A SUITABLE SURGERY PROTOCOL. -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. -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. -THE TIP OF THE BUR OR CUTTER MUST BE IRRIGATED PERIODICALLY (GENERAL RECOMMENDATION: ONCE A MINUTE) TO COOL THE BLADE AND PREVENT EXCISED TISSUES FROM ACCUMULATING. -DO NOT RUN THE INSTRUMENT WITHOUT APPROPRIATE SUCTION FOR THE DURATION OF THE PROCESS. THE REPORTED EVENT WILL CONTINUE TO BE MONITORED THROUGH POST-MARKET SURVEILLANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PIECE (PART OF THE TIP) BROKE OFF THE SHAVER DURING THE CASE. IT DID NOT BREAK OFF IN THE PATIENT. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561127 NA ARTHROSCOPE HRX STRYKER SUSTAINABILITY SOLUTIONS LAKELAND 375-545-000 6329959 00885825014223

    Patients

    Seq Age Sex Outcome Treatment
    1