BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOW PROFILE REAMER 55MM

    MDR report key: 4870831 · Received June 24, 2015

    Report

    Report Number
    9614497-2015-00157
    Event Type
    Malfunction
    Date Received
    June 24, 2015
    Date of Event
    February 9, 2015
    Report Date
    March 4, 2015
    Manufacturer
    GREATBATCH MEDICAL SA
    Product Code
    HTO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT SAMPLE WAS RETURNED FOR EVALUATION AND THE REPORTED EVENT WAS CONFIRMED. A PROCESS REVIEW WAS COMPLETED AND NO DISCREPANCIES WERE FOUND. THE DEVICE SHOWS EVIDENCE OF DULL CUTTING SURFACES FROM END OF LIFE. MANUAL SURGICAL INSTRUMENTS HAVE A LIMITED LIFE-SPAN WHICH IS GENERALLY DETERMINED BY WEAR OR DAMAGE DUE TO REPEATED INTENDED USE. NO FURTHER INVESTIGATION REQUIRED. COMPLAINT INFORMATION PROVIDED BY ZIMMER.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING AN UNKNOWN PATIENT PROCEDURE THE REAMERS WERE FOUND TO BE DULL. NO PATIENT INJURY OR ADVERSE EVENTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410181 LOW PROFILE REAMER 55MM REAMER SHELL HTO GREATBATCH MEDICAL SA 00-7803-090-55 79503000

    Patients

    Seq Age Sex Outcome Treatment
    1