BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IRRIGATION TUBING AND CLIPS, HI-FLOW

    MDR report key: 3189905 · Received June 26, 2013

    Report

    Report Number
    1045834-2013-02524
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    February 28, 2013
    Report Date
    February 28, 2013
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HWE
    PMA / PMN Number
    K063688
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE CUSTOMER REPORTED TWO OCCURRENCES OF THE REPORTED CONDITION AND RETURNED TWO ACTUAL SAMPLES FOR EVALUATION. THE SAMPLES WERE EXAMINED BY RELIABILITY ENGINEERING. VISUAL INSPECTION REVEALED THAT THE PACKAGING WAS IN GOOD CONDITION WITH NO DEFECTS OF THE PEELABLE OR TERMINAL SEALS ON ALL THREE SAMPLES. THE PACKAGING WAS INSPECTED UNDER 10X MAGNIFICATION, AND FOREIGN MATERIAL WAS NOT OBSERVED IN THE PACKAGING OF ALL THREE SAMPLES. THEREFORE, THE REPORTED CONDITION WAS NOT CONFIRMED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SENT ACCORDINGLY. (B)(4).

    Description of Event or Problem · 1

    THIS IS REPORT 2 OF 2. REPORT RECEIVED FROM (B)(6) VIA SYNTHES (B)(6) STATING THAT THERE WAS "RESIDUE FOUND IN STERILE PACK" OF THE DEVICE. THE DEVICE WAS NOT USED DURING SURGERY. THERE WERE NO INJURIES OR MEDICAL INTERVENTION REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290829 IRRIGATION TUBING AND CLIPS, HI-FLOW INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT HWE DEPUY SYNTHES POWER TOOLS MAWD450

    Patients

    Seq Age Sex Outcome Treatment
    1