BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IM REAMER, AO FITTING BIXCUT Ø8,0X480 MM

    MDR report key: 3951689 · Received July 23, 2014

    Report

    Report Number
    0009610622-2014-00368
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 7, 2014
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER

    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

    EVALUATION SUMMARY: THE EVALUATION REVEALED THE REAMER TO BE THE PRIMARY PRODUCT. NO DEVIATIONS WERE FOUND DURING REVIEW OF THE MANUFACTURING AND INSPECTION DOCUMENTS (DHR). THE REAMER RETURNED WAS DOCUMENTED AS FAULTLESS PRIOR TO DISTRIBUTION. DURING INVESTIGATION NO MATERIAL, DESIGN OR MANUFACTURING RELATED ISSUES WERE FOUND. THE UNCOILED OUTER SPIRAL AND THE CONSTRICTED AND BROKEN INNER SPIRAL ARE A RESULT OF DRILLING IN COUNTER-CLOCKWISE DIRECTION. THE WINDING DIRECTION OF THE OUTER SPIRAL ALLOWS ONLY A DRILLING IN CLOCKWISE DIRECTION; IN COUNTER CLOCKWISE DIRECTION THE WINDINGS BECOME UNCOILED. THE INNER SPIRAL IS WINDED TO THE OTHER DIRECTION; THEREFORE IT BECOMES CONSTRICTED IN COUNTER CLOCKWISE DIRECTION. THE IFU INCLUDES THAT THE REAMER SHALL BE NEVER OPERATED IN COUNTER-CLOCKWISE DIRECTION. FURTHERMORE THE USER SHALL BE TRAINED AND FAMILIAR WITH THE SYSTEM AND PRODUCTS. NO NON-CONFORMITY IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE SURGICAL ASSISTANT, THE DOCTOR WAS TRYING DIFFERENT REAMERS IN THE T2 HUMERAL SURGERY. WHEN HE TRIED TO INSERT THE IM REAMER, FITTING BIXCUT 8.0X480 MM (HE HAD TRIED OTHER SIZES PREVIOUS), THE BIXCUT TWISTED, MAKING IMPOSSIBLE TO USE IT. THE SURGEON HAD TO USE ANOTHER SIZE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE SURGICAL ASSISTANT, THE DOCTOR WAS TRYING DIFFERENT REAMERS IN THE T2 HUMERAL SURGERY. WHEN HE TRIED TO INSERT THE IM REAMER, FITTING BIXCUT 8.0X480 MM (HE HAD TRIED OTHER SIZES PREVIOUS), THE BIXCUT TWISTED, MAKING IMPOSSIBLE TO USE IT. THE SURGEON HAD TO USE ANOTHER SIZE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430863 IM REAMER, AO FITTING BIXCUT Ø8,0X480 MM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER TRAUMA KIEL K04A0F6

    Patients

    Seq Age Sex Outcome Treatment
    1 Other