BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK COUPLING FOR K-WIRES

    MDR report key: 3800669 · Received May 8, 2014

    Report

    Report Number
    2520274-2014-11365
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    April 11, 2014
    Report Date
    April 14, 2014
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HWE
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER LOCATION WAS DOCUMENTED AS UNKNOWN IN THE INITIAL REPORT. THE LOCATION HAS BEEN UPDATED TO (B)(4). CONTACT OFFICE NAME/ADDRESS HAS BEEN UPDATED ACCORDINGLY TO REFLECT THE CORRECT MANUFACTURING FACILITY. CORRECTION: THE DEVICE MANUFACTURE DATE WAS DOCUMENTED AS OCT 13, 1999 IN THE INITIAL REPORT. THE DEVICE MANUFACTURE DATE HAS BEEN UPDATED AS JAN 30, 2008. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURE FACILITY WAS UNKNOWN. THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND THE REPORTED CONDITIONS WERE CONFIRMED. A FUNCTIONAL ASSESSMENT WAS PERFORMED WHICH REVEALED THAT SOME OF THE COMPONENTS INSIDE THE DEVICE WERE WORN AND NEEDED TO BE REPLACED. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE MOST LIKELY DUE TO NORMAL WEAR OVER TIME. 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 THAT THE QUICK COUPLING DEVICE WAS MAKING A HIGH PITCHED HUMMING NOISE AND WAS NOT WORKING. THE REPORTER COULD NOT CLARIFY WHETHER THE MALFUNCTION OCCURRED PRIOR TO SURGERY OR DURING SURGERY. THERE WERE NO DELAYS TO A SURGICAL PROCEDURE AS AN IDENTICAL SPARE DEVICE WAS AVAILABLE FOR USE. IT WAS UNKNOWN TO THE REPORTER IF 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
    279508 QUICK COUPLING FOR K-WIRES INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT HWE DEPUY SYNTHES POWER TOOLS 08188

    Patients

    Seq Age Sex Outcome Treatment
    1