BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PKG., AGG. PLUS SHAVER BLADE, F- SERIES - 4.0MM

    MDR report key: 8888445 · Received August 13, 2019

    Report

    Report Number
    0002936485-2019-00338
    Event Type
    Malfunction
    Date Received
    August 13, 2019
    Date of Event
    July 17, 2019
    Report Date
    September 6, 2019
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS LAKELAND
    Product Code
    HRX
    UDI-DI
    37613327061780
    PMA / PMN Number
    K012635
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATES MADE TO THE FOLLOWING SECTIONS: B5, D2, D3, D4, D8, D9, D10, G1, G2, G4, G5, G7, H2, H3, H4, H6, H8, H10. AFTER THE INITIAL MDR WAS FILED, IT WAS DETERMINED THE COMPLAINT DEVICE IS A STRYKER SUSTAINABILITY SOLUTIONS PRODUCT AND NOT A STRYKER ENDOSCOPY PRODUCT. THIS SUPPLEMENTAL MDR DOCUMENTS STRYKER SUSTAINABILITY SOLUTIONS RESPONSIBILITY FOR THE MDR. THE UPDATED INVESTIGATION RESULTS CONFIRM THIS INCIDENT NO LONGER FALLS WITHIN MDR REPORTABILITY REQUIREMENTS AS THERE WERE NO COMPLETELY DETACHED COMPONENTS AT THE FACILITY. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE. THE COMPLAINT DEVICE WAS SUBSEQUENTLY RETURNED TO STRYKER SUSTAINABILITY SOLUTIONS. VISUAL INSPECTION REVEALED EVIDENCE OF CLINICAL USE. DURING INITIAL INSPECTION OF THE RETURNED DEVICE, THE INNER SHAFT TIP WAS OBSERVED TO BE PARTIALLY ATTACHED TO THE SHAFT. HOWEVER, AS THE DEVICE WAS BEING INSPECTED FURTHER, THE INNER SHAFT TIP COMPLETELY DETACHED FROM THE SHAFT. 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 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 · 0

    IT WAS REPORTED THAT THE DEVICE BROKE DURING THE PROCEDURE. PER ADDITIONAL INFORMATION RECEIVED, THE TIP DID NOT FULLY DETACH FROM THE DEVICE. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE DEVICE MANUFACTURE DATE IS NOT KNOWN AT THIS TIME. HOWEVER, SHOULD IT BECOME AVAILABLE IT WILL BE PROVIDED IN FUTURE REPORTS. ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE BROKE DURING THE PROCEDURE. PER ADDITIONAL INFORMATION RECEIVED, THE TIP DID NOT FULLY COME DETACHED FROM THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684295 PKG., AGG. PLUS SHAVER BLADE, F- SERIES - 4.0MM ARTHROSCOPE HRX STRYKER SUSTAINABILITY SOLUTIONS LAKELAND 375-544-000 9779759 37613327061780

    Patients

    Seq Age Sex Outcome Treatment
    1