BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAPERED FINISHING REAMER

    MDR report key: 109642 · Received July 24, 1997

    Report

    Report Number
    2950261-1997-00001
    Event Type
    Malfunction
    Date Received
    July 24, 1997
    Date of Event
    June 25, 1997
    Report Date
    July 12, 1997
    Manufacturer
    SYNVASIVE TECHNOLOGY, INC.
    Product Code
    HTO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO SYNVASICE TECHNOLOGY, INC, THAT: SURGEON WAS USING SYNVASIVE CATALOG #30-0321 "TAPERED FINISHING REAMER", WHICH IS BASICALLY A STAINLESS STEEL BOTTLE BRUSH. DURING USE, THE SHAFT OF THE TAPERED FINISHING REAMER BROKE APPROX 1" FROM THE BRISTLES. AFTER TRYING TO RETRIEVE THE DEVICE, SURGEON DECIDED TO LEAVE FINISHING REAMER FRAGMENT INSIDE OF PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAPERED FINISHING REAMER Implant BONE PREPARATION BRUSH HTO SYNVASIVE TECHNOLOGY, INC. NA 73096

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR