BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4MM FLUTED BALL

    MDR report key: 3240623 · Received July 17, 2013

    Report

    Report Number
    1045834-2013-03521
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    June 1, 2013
    Report Date
    June 17, 2013
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HSZ
    PMA / PMN Number
    K981465
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED. IF ADDITIONAL INFO SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED FROM (B)(6) THAT DURING INCOMING INSPECTION, IT WAS OBSERVED THAT THERE WAS "RESIDUE IN THE STERILE PACKAGE" OF THE DEVICE. THE DEVICE WAS NOT USED IN SURGERY. NO INJURIES OR MEDICAL INTERVENTION WERE REPORTED. THE EXACT DATE OF THE EVENT WAS UNK. ALTHOUGH THE REPORTER CLARIFIED THE EVENT OCCURRED IN (B)(6) 2013. ALL AVAILABLE INFO HAS BEEN DISCLOSED. IF ADDITIONAL INFO SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331824 4MM FLUTED BALL HSZ DEPUY SYNTHES POWER TOOLS F093062555

    Patients

    Seq Age Sex Outcome Treatment
    1