BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RECIPROCATING BLADE, TAPERED

    MDR report key: 1942671 · Received December 22, 2010

    Report

    Report Number
    9616696-2010-00380
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    October 21, 2010
    Report Date
    November 29, 2010
    Manufacturer
    STRYKER IRELAND LTD.
    Product Code
    GFA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BLADE SUBJECT TO THIS MDR WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. LOT NUMBER INFORMATION HAS NOT BEEN PROVIDED TO PERMIT FURTHER INVESTIGATION. THE ROOT CAUSE IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A MEDWATCH THAT THE BLADE BROKE IN HALF WHILE SAWING A PIECE OF BONE. IT WAS ALSO REPORTED THAT THIS EVENT OCCURRED ON A BACK TABLE INVOLVING NO CONTACT WITH THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RECIPROCATING BLADE, TAPERED SAW BLADES & ACCESSORIES GFA STRYKER IRELAND LTD. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK