BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.55MM X 10MM FLUTED TWIST DRL

    MDR report key: 3245512 · Received July 19, 2013

    Report

    Report Number
    1045834-2013-03620
    Event Type
    Malfunction
    Date Received
    July 19, 2013
    Date of Event
    February 28, 2013
    Report Date
    February 28, 2013
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K011444
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED EIGHT OCCURRENCES OF THE REPORTED CONDITION AND RETURNED ELEVEN 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. THE PACKAGING WAS INSPECTED UNDER (B)(4) MAGNIFICATION, AND FOREIGN MATERIAL WAS NOT OBSERVED IN THE PACKAGING. 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 4 OF 8. REPORT RECEIVED FROM (B)(6) REGARDING A CUTTER/BURR DEVICE IN WHICH THE "STERILE PACK WAS DEFORMED". THE ALLEGED DEFECT WAS OBSERVED UPON RECEIPT OF THE PRODUCT, DURING INSPECTION. THEREFORE, THE DEVICE WAS NOT USED IN SURGERY. NO INJURIES OR MEDICAL INTERVENTION WERE REPORTED. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338163 1.55MM X 10MM FLUTED TWIST DRL HBC DEPUY SYNTHES POWER TOOLS F496012477

    Patients

    Seq Age Sex Outcome Treatment
    1