BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    D/M FLUSH CUTTER

    MDR report key: 3010124 · Received March 19, 2013

    Report

    Report Number
    0002249697-2013-01020
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    February 25, 2013
    Report Date
    February 25, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS REPORTED FOR THE REPORTED MANUFACTURING LOT. VISUAL INSPECTION: THE RETURNED DEVICE IS UNREMARKABLE. SOME LIGHT SCRATCHING CONSISTENT WITH NORMAL USE WAS OBSERVED. ADDITIONAL VISUAL INSPECTION WAS PERFORMED AS PART OF THE MATERIAL ANALYSIS REPORT (MAR). IMAGES OF THE DEVICE ARE INCLUDED IN THE MAR. MATERIAL ANALYSIS HAS BEEN PERFORMED, THE REPORTED CONCLUDED: "NO DAMAGE TO DALL MILES FLUSH CUTTER WAS OBSERVED. THE MALE CUTTER HEIGHT WAS ADJUSTED PER DRAWING REQUIREMENTS. THE DALL MILES FLUSH CUTTER FUNCTIONS AS DESIGNED." FUNCTIONAL INSPECTION: THE DEVICE WAS USED TO CUT A SAMPLE OF 2.0MM VITALLIUM DALL MILES CABLE. THE RETURNED DEVICE WAS ABLE TO CUT THE CABLE CLEANLY WITH NORMAL EFFORT AND IS DEEMED FULLY FUNCTIONAL. THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE OF THE REPORTED EVENT DETERMINED BECAUSE THE RETURNED DEVICE WAS FOUND TO BE FULLY FUNCTIONAL. THE RETURNED DEVICE WAS TESTED AND WAS ABLE TO CLEANLY CUT A SAMPLE DALL MILES CABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE D/M FLUSH CUTTER WAS SENT TO THE HOSPITAL , PRIOR TO THE SALES REP ABOUT TO USE TO CUT A D/M CABLE HE NOTICED IT WAS BROKEN AND DID NOT USE. PLACED THE INSTRUMENT ASIDE, AND ALERTED THE OPERATIONS TEAM. THE CASE WENT FINE AND USED A DIFFERENT INSTRUMENT TO COMPLETE THE CASE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE D/M FLUSH CUTTER WAS SENT TO THE HOSPITAL , PRIOR TO THE SALES REP ABOUT TO USE TO CUT A D/M CABLE HE NOTICED IT WAS BROKEN AND DID NOT USE. PLACED THE INSTRUMENT ASIDE, AND ALERTED THE OPERATIONS TEAM. THE CASE WENT FINE AND USED A DIFFERENT INSTRUMENT TO COMPLETE THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113900 D/M FLUSH CUTTER INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH TACA627

    Patients

    Seq Age Sex Outcome Treatment
    1 Other