BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERSUADER FOR 4.0MM RODS

    MDR report key: 7143268 · Received December 22, 2017

    Report

    Report Number
    8030965-2017-50952
    Event Type
    Injury
    Date Received
    December 22, 2017
    Date of Event
    November 24, 2017
    Report Date
    November 24, 2017
    Manufacturer
    OBERDORF : SYNTHES PRODUKTIONS GMBH
    Product Code
    LXH
    UDI-DI
    07611819327146
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE. PART NUMBER: 03.615.009. SYNTHES LOT NUMBER: 7545086, RELEASE TO WAREHOUSE DATE: 25.NOV.2011. MANUFACTURING SITE: (B)(4). AS NON CONFORMANCE REPORT (NCR) WAS OPENED PLEASE REVIEW THE DHR AND PROVIDE A STATEMENT TO IT IF THIS NCR HAD A CONNECTION TO THIS COMPLAINT OR NOT. NCR WAS GENERATED TO CORRECT CHANGES IN ACCORDANCE TO DCOS WHICH HAS BEEN MADE ON COMPONENT (B)(4), DRAWING (B)(4) DURING PRODUCTION OF LOT 7788681. ACCORDING TO THE RATIONALE OF THE PRODUCT DEVELOPER, THE MODIFICATIONS ACCORDING TO DCOS AND NCRS HAVE NO NEGATIVE INFLUENCE ON THE FUNCTION OF THE INSTRUMENT 03.615.009. CONCLUSION AT THE MANUFACTURER'S EXAMINATION, IT HAS BEEN NOTICED THAT THE PINS COMPONENT (B)(4) IN CONTACT WITH THE IMPLANT ARE SEVERELY DAMAGED. THE DIMENSIONS OF THE PINS CAN NO LONGER BE CHECKED AS DEFINED ON DRAWING (B)(4) AFTER THE TUBE HAS BEEN CUT OPEN. A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE 1X ARTICLE 03.615.009 WITH LOT 7545086 / PERSUADER FOR 4.0MM RODS FORWARDED TO MANUFACTURING PLANT HÄGENDORF FOR INVESTIGATION: THE ARTICLE IS IN A USED CONDITION. THE CONNECTION PINS ARE DAMAGED WHICH IS CLEARLY VISIBLE. CONCLUSION: AT THE MANUFACTURER'S EXAMINATION, IT HAS BEEN NOTICED THAT THE PINS IN CONTACT WITH THE IMPLANT ARE SEVERELY DAMAGED. THE DIMENSIONS OF THE PINS CAN NO LONGER BE CHECKED AS DEFINED ON DRAWING (B)(4) AFTER THE TUBE HAS BEEN CUT OPEN. ACCORDING TO THE TEST PLAN AND PQP, IT MUST BE POSSIBLE TO INSERT A TEST PIN WITH A MINIMUM DIAMETER OF 10.5 MM FROM THE FRONT INTO THE OPENING OF THE FORCEPS. THIS TEST COULD BE CARRIED OUT WITHOUT ANY PROBLEMS. THE PLIERS THEMSELVES CAN BE OPENED AND CLOSED WITHOUT CONSPICUOUS FEATURES. NO MANUFACTURING DEFECTS COULD BE DETECTED DURING THE INSPECTION. NO MANUFACTURING RELATED ISSUE WAS IDENTIFIED AND/OR CONFIRMED, THEREFORE REVIEW TO THE SPECIFIC PRM AND PRM LINE IS NOT APPLICABLE. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. 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.

    Additional Manufacturer Narrative · 1

    PATIENT ID/INITIALS AND WEIGHT ARE UNKNOWN. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. (B)(4). THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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 EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2017, SURGERY FOR CERVICAL MYELOPATHY WAS PERFORMED USING THE SYNAPSE 4.0 SYSTEM. THE FIXED AREA WAS C1 ¿ T1. DURING THE SURGERY, ALL SCREWS WERE INSERTED AS PLANNED. TIGHTENING THE ROD ON THE LEFT SIDE WAS SUCCESSFULLY DONE USING THE ROD INTRODUCTIONING INSTRUMENT. HOWEVER, ON THE RIGHT SIDE THIS INSTRUMENT GOT STUCK IN THE SCREW HEAD AND COULD NOT BE REMOVED. THE SURGEON TRIED TO ROTATE THE DEVICE COUNTER-CLOCKWISE AND IMPACTED IT WITH A HAMMER. HE REMOVED THE ROD AND THEN INSERTED A SCREWDRIVER OVER THIS INSTRUMENT. AS A RESULT, HE COULD SUCCESSFULLY REMOVE THIS INSTRUMENT TOGETHER WITH THE SCREW. HE INSERTED A NEW SCREW OF THE SAME SIZE AT THE LOCATION WHERE THE FORMER SCREW WAS BEING INSERTED. AT THE TIME OF ADJUSTING THE DIRECTION OF SCREW HEAD, THE ALIGNMENT TOOL GOT STUCK IN THE SCREW HEADS. THIS EVENT HAPPENED A COUPLE OF TIMES DURING THE SURGERY. THE SURGEON MANAGED TO REMOVE THIS TOOL WHILE HOLDING THE SCREW HEADS WITH A PLIER. NO BROKEN PARTS WERE FOUND LEFT IN THE BODY, AND THE SURGERY WAS DELAYED DUE TO THESE EVENTS BY AN UNKNOWN NUMBER OF MINUTES. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    923297 PERSUADER FOR 4.0MM RODS MISC ORTHO SURGICAL INSTR LXH OBERDORF : SYNTHES PRODUKTIONS GMBH 7545086 07611819327146

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention