BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8CM ANGLE ATTACHMENT

    MDR report key: 3883418 · Received June 19, 2014

    Report

    Report Number
    1045834-2014-12254
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 26, 2014
    Report Date
    May 28, 2014
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    PK011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SERIAL NUMBER WAS UNKNOWN. THEREFORE, THE DATE OF MANUFACTURE WAS UNKNOWN. AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED FROM (B)(6) THAT DURING A VERTEBRAL ARCH FORMING SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE SLEEVE ON THE ATTACHMENT DEVICE ¿LOOSED AND DROPPED.¿ IT WAS FURTHER REPORTED THAT THE SLEEVE DID NOT FALL INTO THE PATIENT. THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE. A SPARE DEVICE WAS NOT AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361469 8CM ANGLE ATTACHMENT MOTOR, DRILL, ELECTRIC - ATTACHMENT HBC DEPUY SYNTHES POWER TOOLS NA

    Patients

    Seq Age Sex Outcome Treatment
    1