BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REAMER SHAFT, AO FITTING BIXCUT Ø8,0X448 MM

    MDR report key: 4220592 · Received November 3, 2014

    Report

    Report Number
    0009610622-2014-00619
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    October 5, 2014
    Report Date
    October 7, 2014
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE EVALUATION REVEALED BOTH RETURNED REAMER SHAFTS 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. DURING INVESTIGATION NO MATERIAL, DESIGN OR MANUFACTURING RELATED ISSUES WERE FOUND. REGARDING DEFORMED SPIRAL OF REAMER SHAFT WITH LOT CODE K0A4452: THE DEFORMATION INDICATES THAT THE AREA OF THE LAST WINDING WAS OVERLOADED BY BENDING FORCES DURING USAGE. MOST LIKELY THE BENDING WAS FAVORED BY MISSING GUIDE WIRE (GUIDE WIRE IN UNDAMAGED CONDITIONS AVOIDS OVERBENDING OF THE REAMER SPIRAL). A THIRD REAMER WAS COMPLAINED; IT BROKE INSIDE THE PATIENT ACCORDING TO THE EVENT DESCRIPTION. DUE TO THE FOUND DAMAGES OF BOTH RETURNED REAMER SHAFTS IT CAN BE ASSUMED THAT THE THIRD REAMER WAS NOT PROVIDED FOR INVESTIGATION. THE IFU CONTAINS THAT THE REAMER SHAFTS SHALL BE OPERATED CAREFULLY TO AVOID DAMAGES; FURTHERMORE DRILLING IN COUNTER-CLOCKWISE DIRECTION AND DRILLING WITHOUT A GUIDE WIRE IS NOT ALLOWED. BECAUSE NO MATERIAL, DESIGN OR MANUFACTURING RELATED ISSUES WERE FOUND A MANUFACTURER RELATED ISSUE CAN BE EXCLUDED; THE CASE IS ATTRIBUTED TO A MISUSE BY THE USER. NO DISCREPANCIES WERE DETECTED DURING RISK ANALYSIS REVIEW. NO NON-CONFORMITY IDENTIFIED; NO ACTIONS ARE IN PLACE.

    Description of Event or Problem · 1

    RISK MANAGER REPORTED THE FOLLOWING EVENT : "DURING A PROCEDURE FOR IMPLANTATION OF AN S2 NAIL, LEFT FEMUR, THE REAMER SHAFT FRACTURED INTO THE PATIENT DURING THE FIRST REAMING. ANOTHER SHAFT WAS USED WHICH FRACTURED OUT OF THE PATIENT, AND TO FINISH THE PROCEDURE, A THIRD SHAFT WAS USED WHICH WAS CLOSE TO BREAKAGE."

    Description of Event or Problem · 1

    RISK MANAGER REPORTED THE FOLLOWING EVENT : "DURING A PROCEDURE FOR IMPLANTATION OF AN S2 NAIL, LEFT FEMUR, THE REAMER SHAFT FRACTURED INTO THE PATIENT DURING THE FIRST REAMING. ANOTHER SHAFT WAS USED WHICH FRACTURED OUT OF THE PATIENT, AND TO FINISH THE PROCEDURE, A THIRD SHAFT WAS USED WHICH WAS CLOSE TO BREAKAGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702539 REAMER SHAFT, AO FITTING BIXCUT Ø8,0X448 MM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER TRAUMA KIEL K0A4452

    Patients

    Seq Age Sex Outcome Treatment
    1 Other