BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IM REAMER, AO FITTING BIXCUT Ø7,5X480 MM

    MDR report key: 3720933 · Received April 2, 2014

    Report

    Report Number
    0009610622-2014-00144
    Event Type
    Malfunction
    Date Received
    April 2, 2014
    Date of Event
    March 5, 2014
    Report Date
    March 5, 2014
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE REPORTED ISSUE WAS CONFIRMED. ALL REAMERS ARE CLASSIFIED TO BE PRIMARY PRODUCTS. NO DEVIATIONS WERE FOUND DURING REVIEW OF THE MANUFACTURING AND INSPECTION DOCUMENTS (DHR). THE ITEMS RETURNED WERE DOCUMENTED AS FAULTLESS PRIOR TO DISTRIBUTION. AS THE DEVICE HAD BEEN IN USE FOR A MINIMUM OF APPROX. ONE YEAR WE PRE-SUPPOSE THAT THEY HAD FULFILLED THEIR TASKS IN FORMER SURGERIES AS INTENDED. REGARDING DEFORMED SHAFTS / INNER SPIRAL CONSTRICTION: ALL SHAFTS WERE DEFORMED DUE TO OVER BENDING, ALSO EVERY DEFORMED FIRST AND LAST WINDING OF THE OUTER SPIRAL IS A RESULT OF OVER BENDING. THE CONSTRICTED INNER SPIRAL OF THE REAMER WITH LOT CODE K290084 BLOCKS THE INNER DIAMETER AND A GUIDE WIRE INSERTION IS NO LONGER POSSIBLE. PREVIOUS COMPLAINTS ARE KNOWN REPORTING THE SAME ISSUE. DURING INVESTIGATION SOME REAMERS WERE EVALUATED BY AN EXTERNAL LAB (SEE NUTECH LAB REPORT (B)(4). THE INVESTIGATION REVEALED THAT THE MATERIAL OF THE FLEXIBLE SPIRAL IS WITHIN SPECIFICATIONS. FURTHERMORE THE WELDING PROCESS ¿ORBITAL WELDING¿ LEADS TO A BIGGER HEAT AFFECTED ZONE THAN THE OLD WELDING PROCESS ¿ELECTRON BEAM WELDING¿. THE HEAT AFFECTED ZONE REDUCES THE HARDNESS OF THE LAST WINDING OF THE INNER SPIRAL TO APPROX. 50%. DUE TO OVER BEND THE AREA FLEXIBLE SHAFT TO INFLEXIBLE HEAD/ADAPTER IT IS POSSIBLE THAT THE INNER SPIRAL GOT PLASTICALLY DEFORMED AT THE POINT WHERE THE HARDNESS IS REDUCED; A GUIDE WIRE INSERTION IS NO LONGER POSSIBLE. IT IS MOST LIKELY THAT THE INNER SPIRAL GETS PLASTICALLY DEFORMED DURING CLEANING: TO CLEAN THE FLEXIBLE SPIRAL IT IS OFTEN NECESSARY TO BEND THE FLEXIBLE SHAFT MANUALLY WITHOUT AN INSERTED GUIDE WIRE. NEAR THE CUTTING HEAD AND THE ADAPTER THE FLEXIBLE AREA RUNS OVER INTO THE UN-FLEXIBLE ADAPTER AND CUTTING HEAD. BENDING OF THESE AREAS CAUSED A LOT OF STRESSES TO THE MATERIAL; IN COMBINATION WITH THE WEAK SPOTS AND TOO HIGH BENDING FORCES THE INNER SPIRAL COULD BE PLASTICALLY DEFORMED. HOWEVER, OVER BENDING OF THE REAMER IS RELATED TO AN IMPROPER HANDLING/CLEANING. REGARDING DAMAGES CUTTING EDGES: THE HEAVY DEFORMATIONS, DENTS AND SCRATCHES ARE THE RESULT OF DRILLING METAL; SIGNS OF A SHARPENING REPAIR ARE NOT VISIBLE. THE IFU INFORMS THAT DRILLING METAL AND A SHARPENING REPAIR IS NOT ALLOWED (USER ERROR). REGARDING UNCOILED OUTER SPIRAL: THE SHAFT OF THE REAMER WITH LOT CODE K272752 IS SLIGHTLY UNCOILED; THIS IS THE RESULT OF COUNTER CLOCKWISE ROTATION DURING DRILLING. THE IFU INFORMS THAT COUNTER CLOCKWISE ROTATION IS NOT ALLOWED AND CAN LEAD TO ADDITIONAL TRAUMA (USER ERROR). NO DISCREPANCIES WERE DETECTED DURING RISK ANALYSIS REVIEW. NO NON-CONFORMITY IDENTIFIED; NO ACTIONS ARE IN PLACE.

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE REAMERS HAVE COME FROM CASES AND/OR OUTSIDE SHARPENING REPAIR, WERE FOUND WITH SEPARATIONS IN BINDING WHICH CAN CAUSE THE BINDING TO UNRAVEL AT DISTAL OR PROXIMAL END.

    Description of Event or Problem · 1

    THE REAMERS HAVE COME FROM CASES AND/OR OUTSIDE SHARPENING REPAIR, WERE FOUND WITH SEPARATIONS IN BINDING WHICH CAN CAUSE THE BINDING TO UNRAVEL AT DISTAL OR PROXIMAL END.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    198700 IM REAMER, AO FITTING BIXCUT Ø7,5X480 MM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER TRAUMA KIEL K253857

    Patients

    Seq Age Sex Outcome Treatment
    1 Other