BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LARGE QUICK COUPLING

    MDR report key: 5608655 · Received April 26, 2016

    Report

    Report Number
    2520274-2016-12287
    Event Type
    Malfunction
    Date Received
    April 26, 2016
    Date of Event
    February 22, 2016
    Report Date
    April 12, 2016
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HWE
    PMA / PMN Number
    PK971544
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SERIAL NUMBER AND DEVICE MANUFACTURE DATE: THE DEVICE SERIAL NUMBER PROVIDED BY THE REPORTER IN THE INITIAL REPORT WAS INCORRECT ((B)(4)). THEREFORE, THE MANUFACTURE DATE WAS UNKNOWN. UPON RECEIPT OF THE DEVICE THE SERIAL NUMBER WAS IDENTIFIED AS (B)(4). THE DEVICE MANUFACTURE DATE HAS BEEN UPDATED TO FEB 2, 2010. THE ACTUAL DEVICE HAS BEEN RETURNED AND IS CURRENTLY PENDING EVALUATION. ONCE RELIABILITY ENGINEERING EVALUATES THE DEVICE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY. 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

    (B)(6). THE MANUFACTURING LOCATION IS CURRENTLY NOT AVAILABLE. THE DEVICE MANUFACTURE DATE IS CURRENTLY NOT AVAILABLE. 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: BRAND NAME: THE DEVICE BRAND NAME WAS INCORRECTLY DOCUMENTED. THE BRAND NAME HAS BEEN UPDATED FROM QC F/DHS/DCS TRIPLE REAMERS TO LARGE QUICK COUPLING. THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE. A FUNCTIONAL ASSESSMENT WAS PERFORMED AND THE DEVICE WORKED AS EXPECTED AND THERE WERE NO MISSING PARTS IDENTIFIED. NO FAILURES WERE IDENTIFIED. THE REPORTED CONDITION WAS NOT CONFIRMED. THEREFORE, AN ASSIGNABLE ROOT CAUSE WAS NOT DETERMINED. 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

    THE MANUFACTURER LOCATION WAS DOCUMENTED AS UNKNOWN IN THE INITIAL REPORT. THE LOCATION HAS BEEN UPDATED TO WALDENBURG. CONTACT OFFICE NAME/ADDRESS HAS BEEN UPDATED ACCORDINGLY TO REFLECT THE CORRECTED MANUFACTURING FACILITY. DEVICE MANUFACTURE DATE: THE DEVICE MANUFACTURE DATE WAS DOCUMENTED AS UNKNOWN IN THE INITIAL REPORT. THE DEVICE MANUFACTURE DATE HAS BEEN UPDATED AS AUG 13, 2009. 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 A PIECE OF NUT (DRILL ADAPTOR, APPROX. 2MM X 2MM) WAS FOUND MISSING FROM THE QUICK COUPLING REAMER DEVICE WHEN THE DEVICE COUNT CHECK WAS PERFORMED AFTER FINISHING AN OPERATION. THERE WAS NO PATIENT INVOLVEMENT REPORTED. 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
    262637 LARGE QUICK COUPLING INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT HWE DEPUY SYNTHES POWER TOOLS N/A

    Patients

    Seq Age Sex Outcome Treatment
    1