BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DHS®/DCS® COUPLING SCREW

    MDR report key: 3953439 · Received July 23, 2014

    Report

    Report Number
    3003875359-2014-10218
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 25, 2014
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    HWB
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. 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

    ADDITIONAL NARRATIVE: A MANUFACTURING EVALUATION WAS COMPLETED: THE TIPS OF THE CONNECTION SCREW IS BROKEN. AS REPORTED IN THE DEVICE REPORT, THE IMPLANT WRENCH WAS USED IN ERROR FOR THIS SURGERY. A REVIEW ALSO CONFIRMS THAT THE INCORRECT SCREW WAS ALSO USED. THE SURGERY WAS FOR REMOVAL OF DYNAMIC HIP SCREW PLATE AND SCREW CONSTRUCT, WHICH REQUIRED THE USE OF DIFFERENT SCREW AND WRENCH PART NUMBERS AS DETAILED IN TECHNIQUE GUIDE. THE ARTICLES RETURNED, ARE NOT DESIGNED TO WITHSTAND THE EXTREME TORQUE THAT IS REQUIRED FOR SCREW/PLATE REMOVAL. THOUGH THE INCORRECT ARTICLES WERE USED FOR THE SURGERY A FULL REVIEW OF THE MANUFACTURING RECORDS FOR THE ARTICLES RETURNED WAS CONDUCTED. THE CONNECTION SCREW WAS MANUFACTURED IN JULY 2013 AND ALL MET MANUFACTURING SPECIFICATIONS. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT AN OPERATION WAS PERFORMED TO REMOVE A DYNAMIC HIP SCREW (DHS) PLATE AND SCREW CONSTRUCT. THE DHS PLATE WAS REMOVED TO PREPARE FOR A HIP REPLACEMENT THAT IS PLANNED TO TAKE PLACE IN THE FUTURE. THE SCREW WAS FOUND TO BE TIGHT WITHIN THE PLATE/BONE. AS ROTATIONAL FORCE WAS PUT THROUGH THE WRENCH TO UNWIND THE SCREW THE TIPS OF BOTH THE WRENCH AND CONNECTING SCREW BROKE OFF. BROKEN PIECES WERE EASILY RETRIEVED WITH MINIMAL DELAY, NO MORE THAN TWO MINUTES. THE INSERTION WRENCH WAS USED IN THIS CASE AS IT WAS NOT IDENTIFIED AS BEING FOR INSERTION ONLY. UNDER THE BRIGHT LIGHTS IN THE OPERATING ROOM THE FINE WRITING ON THE HANDLE OF THE WRENCH (FOR INSERTION ONLY) WAS NOT CLEARLY IDENTIFIABLE FOR THE OPERATING ROOM STAFF. THE SCREW WAS REMOVED USING A COMBINATION OF THE EXTRACTION INSTRUMENT (338.060) AND USING THE PLATE TO REMOVE THE SCREW. THERE WAS NO PATIENT HARM REPORTED. THIS REPORT IS 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430696 DHS®/DCS® COUPLING SCREW EXTRACTOR HWB SYNTHES HAGENDORF 8481314

    Patients

    Seq Age Sex Outcome Treatment
    1