BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAGITTAL BLADE

    MDR report key: 1872620 · Received October 5, 2010

    Report

    Report Number
    9616696-2010-00291
    Event Type
    Injury
    Date Received
    October 5, 2010
    Date of Event
    June 21, 2010
    Report Date
    September 8, 2010
    Manufacturer
    STRYKER IRELAND LTD.
    Product Code
    HWE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BLADE SUBJECT TO THIS MDR HAS BEEN DISCARDED. LOT NUMBER INFORMATION HAS NOT BEEN PROVIDED TO PERMIT FURTHER INVESTIGATION. THE ROOT CAUSE IS MULTI-FACTORIAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY PROCEDURE THAT THE BLADE BROKE AT THE MOUNT. IT WAS ALSO REPORTED THAT A SECOND SURGERY WAS REQUIRED TO REMOVE THE BROKEN PIECE OF THE BLADE. IT WAS ALSO REPORTED THAT THE PATIENT WAS FINE AFTER BOTH SURGERIES AND THERE WERE NO FURTHER COMPLICATIONS TO THE KNEE AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAGITTAL BLADE SAW BLADES AND ACCESSORIES HWE STRYKER IRELAND LTD. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention