BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARREL REAMER ASSEMBLY STANDARD

    MDR report key: 6572807 · Received May 17, 2017

    Report

    Report Number
    0008031020-2017-00302
    Event Type
    Malfunction
    Date Received
    May 17, 2017
    Date of Event
    April 20, 2017
    Report Date
    November 6, 2017
    Manufacturer
    STRYKER GMBH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    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

    THE REPORTED EVENT THAT ONE COMPONENT OF A BARREL REAMER ASSEMBLY STANDARD CATCHES ON THE NUT AS IT PASSES OVER IT AND LEADS TO METAL DEBRIS COULD NOT BE CONFIRMED SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER EVIDENCES WERE PROVIDED. MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT AS WELL AS THE AFFECTED DEVICE MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT. HOWEVER, THIS DOES NOT CONSTITUTE A PROBLEM, AS A TRANSITION FIT BETWEEN PART# 704005-4 AND PART# 704005-3 IS INTENTIONAL. IT AIMS TO AVOID DISASSEMBLY OF THESE COMPONENTS DURING SURGERY WHEN USING THE POWER TOOL. MOREOVER, THE ASSEMBLY OF PART# 704005-4 WITH PART# 704005-3 IS TO BE DONE OUT OF SURGERY. A REVIEW OF THE DEVICE HISTORY WAS NOT POSSIBLE BECAUSE THE LOT NUMBER WAS NOT COMMUNICATED. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. IF ANY FURTHER INFORMATION IS PROVIDED, THE INVESTIGATION REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    THE CUSTOMER, REPORTED THAT WHEN HE SCREWS THE 2 PIECES OF THE OMEGA BARREL REAMER TOGETHER, THEY SHEAR AGAINST EACH OTHER AND HE IS CONCERNED ABOUT PIECES OF METAL COMING OFF.

    Description of Event or Problem · 1

    THE CUSTOMER, REPORTED THAT WHEN HE SCREWS THE 2 PIECES OF THE OMEGA BARREL REAMER TOGETHER THEY SHEAR AGAINST EACH OTHER AND HE IS CONCERNED ABOUT PIECES OF METAL COMING OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353461 BARREL REAMER ASSEMBLY STANDARD ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other