BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.85MM X 16MM FLUTED ROUTER

    MDR report key: 3579700 · Received January 16, 2014

    Report

    Report Number
    1045834-2014-11161
    Event Type
    Injury
    Date Received
    January 16, 2014
    Date of Event
    December 17, 2013
    Report Date
    December 18, 2013
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    GFF
    PMA / PMN Number
    PK974025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER OF THE DEVICE WAS UNKNOWN AT THE TIME OF THE REPORT. THEREFORE, THE DATE OF MANUFACTURER IS UNKNOWN. THE DEVICE HAS NOT BEEN RETURNED AS THIS IS A SINGLE-USE INSTRUMENT; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY.

    Description of Event or Problem · 1

    THIS IS REPORT 2 OF 2 FOR THE SAME EVENT. IT WAS REPORTED FROM (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE CUTTER DEVICE WAS ¿BROKEN OFF IN THE GENERAL PROCEDURE¿. THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE. IT WAS UNKNOWN IF A SPARE DEVICE WAS AVAILABLE FOR USE. HOWEVER, IT WAS REPORTED THAT THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO INFORMATION AVAILABLE REGARDS WHETHER OR NOT AN X-RAY WAS DONE TO VERIFY THAT ALL BROKEN PIECES OF THE DEVICE WERE RETRIEVED, BUT THE REPORTER INDICATED THAT ALL PIECES WERE RETRIEVED. THERE WERE NO INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42114 1.85MM X 16MM FLUTED ROUTER BUR, SURGICAL, GENERAL & PLASTIC SURGERY - CUTTING BURR GFF DEPUY SYNTHES POWER TOOLS NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention