BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TWIST DRILL-1.5MMX6MM SCRW

    MDR report key: 3140669 · Received May 31, 2013

    Report

    Report Number
    1045834-2013-02245
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Date of Event
    February 28, 2013
    Report Date
    February 28, 2013
    Manufacturer
    DEPUY SNYTHES POWER TOOLS
    Product Code
    HSZ
    PMA / PMN Number
    K955084
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUTTER/BURR DEVICE WAS NOT RECEIVED FOR EVALUATION. THEREFORE, THE REPORTED CONDITION WAS NOT CONFIRMED. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE. VISUAL INSPECTION REVEALED THAT THE PACKAGING WAS IN GOOD CONDITION WITH NO DEFECTS OF THE PEELABLE OR TERMINAL SEAL. THE PACKAGING WAS INSPECTED UNDER 10X MAGNIFICATION, AND FOREIGN MATERIAL WAS NOT OBSERVED IN THE DEVICE PACKAGING. THEREFORE, THE REPORTED CONDITION WAS NOT CONFIRMED. (B)(4).

    Description of Event or Problem · 1

    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
    242103 TWIST DRILL-1.5MMX6MM SCRW INSTRUMENT, SURGICAL, ORTHOPEDIC, PNEUMATIC POWERED - CUTTER HSZ DEPUY SNYTHES POWER TOOLS D293037351

    Patients

    Seq Age Sex Outcome Treatment
    1