BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCOLADE TMZF FEMORAL RASP SIZE 3

    MDR report key: 2510490 · Received March 27, 2012

    Report

    Report Number
    2249697-2012-00361
    Event Type
    Injury
    Date Received
    March 27, 2012
    Date of Event
    March 9, 2012
    Report Date
    March 9, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    HTR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE POST OF THE "ACCOLADE TMZF FEMORAL RASP SIZE 3" WAS BROKEN DURING RASPING IN OP. THE RASP REMAINED IN THE CANAL AND COULD NOT BE REMOVED, BECAUSE THE RASP HANDLE COULD NOT BE ATTACHED WITH THE RASP. SO, THE SURGEON GAUGED FEMUR AND CREATE INTERSPACE BETWEEN THE RASP AND THE CANAL. THEN, HE INSERTED THE TIPS OF THE BONE FORCEPS INTO THE INTERSPACE AND SLITS OF THE RASP. AND HE COULD REMOVE THE RASP WITH BONE FORCEPS AND THE SLITS OF THE RASP. THERE WAS A 10 MINUTES DELAY IN OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCOLADE TMZF FEMORAL RASP SIZE 3 INSTRUMENT HTR STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other