BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WICHITA FUSION TIBIAL REAMER

    MDR report key: 3120672 · Received May 20, 2013

    Report

    Report Number
    0002249697-2013-01722
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Date of Event
    April 26, 2013
    Report Date
    April 26, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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

    REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THE LOT WAS MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. THE RETURNED DEVICE WAS IN USED CONDITION. SMALL NICKS AND SCRATCHES WERE NOTED ON THE DEVICE CONSISTENT WITH NORMAL USE. INSPECTION OF THE DEVICE FOUND NO EVIDENCE THAT IT WAS "BADLY BENT" NOR WERE ANY OTHER GROSS DAMAGES NOTED. THE THE ROOT CAUSE OF THE REPORTED EVENT DETERMINED BECAUSE INSPECTION OF THE RETURNED DEVICE COULD NOT CONFIRM THE EVENT. THE RETURNED REAMER WAS IN GOOD CONDITION AND WAS NOT BENT. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    TIBIAL REAMER FROM THE WICHITA SET THAT WAS DELIVERED AS A LOANER INSTRUMENT SET WAS BADLY BENT. NO REPLACEMENT DEVICE WAS USED, NO DELAY IN SURGICAL TIME, SURGEON NOTICED WHEN HE SPUN THE REAMER ON POWER DRIVER THAT IS WAS BADLY BENT.

    Description of Event or Problem · 1

    TIBIAL REAMER FROM THE WICHITA SET THAT WAS DELIVERED AS A LOANER INSTRUMENT SET WAS BADLY BENT. NO REPLACEMENT DEVICE WAS USED, NO DELAY IN SURGICAL TIME, SURGEON NOTICED WHEN HE SPUN THE REAMER ON POWER DRIVER THAT IS WAS BADLY BENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222304 WICHITA FUSION TIBIAL REAMER INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH TBNG101

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Other