BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAGITTAL SAW ATTACHMENT FOR PEN DRIVE

    MDR report key: 6054751 · Received October 25, 2016

    Report

    Report Number
    8030965-2016-15293
    Event Type
    Malfunction
    Date Received
    October 25, 2016
    Date of Event
    October 6, 2016
    Report Date
    October 11, 2016
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HWE
    PMA / PMN Number
    K043310
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: (B)(4). 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

    THIS IS REPORT 2 OF 3 FOR THE SAME EVENT: IT WAS REPORTED THAT DURING A HUMERUS SURGERY, IT WAS DISCOVERED THAT THE ELECTRIC PEN DRIVE DEVICE, SAGITTAL SAW ATTACHMENT DEVICE AND THE CABLE DEVICE WERE NOT WORKING AT ALL AND HAD NO POWER. THERE WAS A ONE HUNDRED AND EIGHTY MINUTE DELAY TO THE SURGICAL PROCEDURE BECAUSE SPARE DEVICES WERE NOT AVAILABLE FOR USE. IT WAS UNKNOWN HOW THE SURGERY WAS COMPLETED. THE REPORTER INDICATED THAT THEY WERE NOT SURE IF ALL OF THE THREE DEVICES WERE DEFECTIVE. IT WAS REPORTED THAT THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS PATIENT INVOLVEMENT REPORTED. ACCORDING TO THE REPORTER, THE PATIENT DID NOT HAVE ANY COMPLICATIONS AND NO ONE WAS HURT. IT WAS REPORTED THAT THE PATIENT RECOVERED WITHOUT ANY ISSUES OR COMPLICATIONS. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE REPORTER STATED THAT THE SAGITTAL SAW ATTACHMENT DEVICE AND THE CABLE DEVICE WERE TESTED WITH A NEW HANDLE DEVICE AND THEY WORKED FINE. 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
    707407 SAGITTAL SAW ATTACHMENT FOR PEN DRIVE INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT HWE DEPUY SYNTHES POWER TOOLS 3556807

    Patients

    Seq Age Sex Outcome Treatment
    1 CABLE DEVICE| ELECTRIC PEN DRIVE /HANDLE DEVICE