BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELF-RETAINING SCREWDRIVER FORQUICK LOCK SCREWS 275MM

    MDR report key: 5488911 · Received March 9, 2016

    Report

    Report Number
    1719045-2016-10205
    Event Type
    Malfunction
    Date Received
    March 9, 2016
    Report Date
    January 26, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HXX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE (SELF-RETAINING SCREWDRIVER FOR QUICK LOCK SCREWS 275MM, PART NUMBER 03.610.603, LOT NUMBER 6164747, SUPPLIER LOT NUMBER 4790802). THE RETURNED DEVICE WAS EXAMINED AND IT WAS CONFIRMED THAT THE DISTAL TOP WAS DEFORMED (BENT) AS COMPLAINED. ADDITIONALLY, THE INSTRUMENT WAS FOUND TO HAVE A BROKEN AND MISSING PRONG. THE RELEVANT DRAWINGS FOR THE SUBJECT DEVICE WERE REVIEWED. THE DESIGN, MATERIALS AND FINISHING PROCESSES WERE FOUND TO BE APPROPRIATE FOR THE INTENDED USE OF THIS DEVICE. THE DEVICE HISTORY REVIEW FOR LOT 6164747 IDENTIFIED A NON-CONFORMANCE REPORT (NCR) FOR INSPECTION FEATURES 4 (END DIAMETER COUNTER BORE), 5 (END DIAMETER STEP) AND 6 (POSITION AND DEPTH OF PRONGS). THE FULL LOT WAS INSPECTED AND ONE INSTRUMENT WAS FOUND TO BE OUT OF SPECIFICATION AND WAS SCRAPPED. AS ALL RELEASED INSTRUMENTS WERE INSPECTED AND FOUND TO BE WITHIN SPECIFICATION AT THE TIME OF RELEASE; THE NCR IS DEEMED UNRELATED TO THE RECEIVED COMPLAINT CONDITION. A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED HOWEVER THE COMPLAINT CONDITION IS CONSISTENT WITH WEAR/TEAR AND/OR IMPROPER TECHNIQUE. 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 INITIALLY REPORTED ON (B)(6) 2016, THAT THE SELF-RETAINING SCREWDRIVER FOR QUICK LOCK SCREWS HAD BENT PRONGS. THE COMPLAINT CONDITION WAS DISCOVERED DURING INSTRUMENT INSPECTION BY STERILE PROCESSING ON (B)(6) 2016 AND THERE WAS NO REPORTED PATIENT OR SURGICAL INVOLVEMENT. THIS EVENT WAS INITIALLY DETERMINED TO BE NON-REPORTABLE. ON (B)(6) 2014, DURING INVESTIGATION OF THE RETURNED INSTRUMENT BY THE SYNTHES MANUFACTURER, IT WAS NOTED THAT THE INSTRUMENT HAD A MISSING PRONG. THE COMPLAINT WAS RE-EVALUATED BASED ON THIS CONDITION AND DETERMINED TO BE A REPORTABLE MALFUNCTION. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145873 SELF-RETAINING SCREWDRIVER FORQUICK LOCK SCREWS 275MM SCREWDRIVERS HXX SYNTHES MONUMENT 6164747

    Patients

    Seq Age Sex Outcome Treatment
    1