BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.5 MM X 25.4 MM FLUTED ROUTER

    MDR report key: 3983736 · Received December 18, 2013

    Report

    Report Number
    1045834-2013-14569
    Event Type
    Malfunction
    Date Received
    December 18, 2013
    Report Date
    June 22, 2012
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    GFF
    PMA / PMN Number
    K974025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED AND EVALUATED BY DEPUY SYNTHES POWER TOOLS. THE REPORTED CONDITION OF "FAILED DISTRIBUTOR'S INSPECTION" COULD NOT BE CONFIRMED. VISUAL INSPECTION FOUND NO LOOSE FOREIGN MATERIAL ON THE DEVICE WHEN INSPECTED AT 10X MAGNIFICATION. THE PACKAGE WAS IN GOOD CONDITION WITH NO DEFECTS OF THE PEELABLE OR TERMINAL SEAL. IF ADDITIONAL INFO BECOMES AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED. REF: (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM (B)(6) STATING THAT THE DEVICE WAS RETURNED DUE TO "RETURNED PRODUCT UNUSED - INCOMING ORDER FAILED DISTRIBUTOR'S INSPECTIONS." THE DEVICE WAS NOT BEING USED DURING SURGERY AND NO INJURY OR MEDICAL INTERVENTION OCCURRED. THE DATE OF EVENT IS UNK. THERE WAS NO ADDITIONAL INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663832 2.5 MM X 25.4 MM FLUTED ROUTER GFF DEPUY SYNTHES POWER TOOLS E163049015

    Patients

    Seq Age Sex Outcome Treatment
    1