BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IRRIGATION CONTROL UNIT F/APD

    MDR report key: 6632267 · Received June 9, 2017

    Report

    Report Number
    8030965-2017-12918
    Event Type
    Malfunction
    Date Received
    June 9, 2017
    Date of Event
    May 16, 2017
    Report Date
    May 17, 2017
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HWE
    PMA / PMN Number
    K043310
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). THE MANUFACTURING LOCATION WAS UNKNOWN. DEVICE MANUFACTURE DATE IS 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.

    Additional Manufacturer Narrative · 1

    CORRECTION: UPON FURTHER INVESTIGATION, IT WAS DETERMINED THAT MFR# 8030965-2017- 12918 IS A DUPLICATE OF MFR# 8030965-2017-12836. REFERENCE MFR# 8030965-2017-12836 FOR ALL FURTHER REPORTING REGARDING THIS EVENT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED FROM (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE IRRIGATION CONTROL DEVICE WAS BLOCKING DURING USE. THERE WERE NO DELAYS TO THE PLANNED SURGICAL PROCEDURE. A SPARE DEVICE WAS AVAILABLE FOR USE TO COMPLETE THE PROCEDURE. 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
    411601 IRRIGATION CONTROL UNIT F/APD INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT HWE DEPUY SYNTHES POWER TOOLS 2837

    Patients

    Seq Age Sex Outcome Treatment
    1