BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.15MM X 22MM SPIRAL ROUTER

    MDR report key: 3969734 · Received December 9, 2013

    Report

    Report Number
    1045834-2013-07022
    Event Type
    Malfunction
    Date Received
    December 9, 2013
    Report Date
    August 9, 2012
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED BY DEPUY SYNTHES POWER TOOLS. THE DEVICE WAS EVALUATED AND THE CONDITION COULD NOT BE CONFIRMED. VISUAL INSPECTION ACCEPTANCE CRITERIA ARE "NO LOOSE FOREIGN MATERIAL (LFM) WHEN INSPECTED AT 1X MAGNIFICATION." NO LFM COULD BE FOUND ON THE DEVICE WHEN INSPECTED AT 10X MAGNIFICATION. ALSO, THE PACKAGE IS IN GOOD CONDITION WITH NO DEFECTS OF THE PEELABLE OR TERMINAL SEAL.

    Description of Event or Problem · 1

    REPORT RECEIVED FROM (B)(6), STATING THAT THERE WAS DEBRIS INSIDE THE STERILE PACKAGING. THE DEVICE WAS NOT BEING USED IN SURGERY. THERE WAS NO INJURY OR MEDICAL INTERVENTION. THE DATE OF EVENT IS UNK. THERE WAS NO ADD'L INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639508 2.15MM X 22MM SPIRAL ROUTER HBC DEPUY SYNTHES POWER TOOLS F043060946

    Patients

    Seq Age Sex Outcome Treatment
    1