BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUTION SQUID TOOL FOR ASSEMBLY AND DISASSEMBLY

    MDR report key: 8160469 · Received December 13, 2018

    Report

    Report Number
    8030965-2018-58995
    Event Type
    Malfunction
    Date Received
    December 13, 2018
    Date of Event
    October 12, 2018
    Report Date
    November 8, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    LXH
    UDI-DI
    07611819534513
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PART: 03.815.029, LOT: 9901096, MANUFACTURING SITE: HÄGENDORF, RELEASE TO WAREHOUSE DATE: 18.APR.2016. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF (B)(4) PIECES WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMITIES NOTED. THIS LOT MET ALL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURING PROCESS. ONLY TOP LEVEL OF THE DEVICE HISTORY RECORD REVIEWED AS SUB-COMPONENTS ARE NOT LOT TRACKED. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A PRODUCT INVESTIGATION WAS CONDUCTED. YES, THE RECEIVED CONDITION AGREES WITH THE COMPLAINT DESCRIPTION. YES, THE COMPLAINT CAN BE REPLICATED WITH THE RETURNED DEVICE. NO, A DESIGN DEFECT OR DEFICIENCY DID NOT CONTRIBUTE TO THE COMPLAINT CONDITION. BELOW A SUMMARY OF THE PRODUCT DEVELOPMENT INVESTIGATION FROM OBERDORF RECEIVED CONDITION OF DEVICE: CUSTOMER RETURNED 4 PARTS. EVOLSQUID SYNTHES QUICK INSERT+DISTRACT ART. NO.: 03.815.030: BOTH RETURNED INSTRUMENTS ARE IN A SOUND CONDITION AND SHOW NORMAL SIGNS OF USAGE. EVOLSQUID ASSEMB / DISASSEMB TOOL ART. NO.: 03.815.029: THE TWO PPSU TOOLS ARE AS THE OTHER TWO INSTRUMENTS IN A SOUND CONDITION. ON THE SURFACES WHERE THE INSERTER AND DISTRACTOR INSTRUMENT GLIDES, ARE GRINDING MARKS VISIBLE. THE RETURNED INSTRUMENTS SHOW VISIBLE TRACES OF WEAR WHICH COULD POTENTIALLY BE THE CAUSE OF THE OBSERVED SLICES ON THE A-D TOOL. ACCORDING TO OUR IMPORTANT INFORMATION IFU (SE_023827) DAMAGED AND EXCESSIVELY WORN DEVICES SHOULD NOT BE USED ANYMORE. THEREFORE, IT CAN BE STATED THAT THE BLACK PPSU SLICES WOULD NOT BE PUSHED INTO THE WOUND WITH THE CAGE. 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

    OCCUPATION: INITIAL REPORTER IS SYNTHES SALES REPRESENTATIVE. THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. 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 REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2018, AN ANTERIOR LUMBAR INTERBODY FUSION (ALIF) OFFICE PRESENTATION INVOLVED DEMONSTRATING THE EVOLV SQUID SYNTHES DEVICE. THE ISSUE OCCURRED WHEN ASSEMBLING THE EVOLSQUID SYNTHES QUICK INSERT+DISTRACT DEVICE (SILVER RAIL WITH GREEN HANDLE) THAT SLIDES OVER THE EVOLSQUID ASSEMB / DISASSEMB TOOL DEVICE (BLACK THREE PIECE). THIS SLIDING MECHANISM WOULD REMOVE SLICES OF THE BLACK RAIL AND MAKE A CARVING NOISE WHILE SLIDING THE INSERTER OVER IT. THE DEMONSTRATION WAS DONE AROUND TEN TIMES WHEN THE DEVICE BEGINS STRIPPING THE BLACK PLASTIC. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) EVOLUTION SQUID TOOL FOR ASSEMBLY AND DISASSEMBLY. THIS IS REPORT 3 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1002704 EVOLUTION SQUID TOOL FOR ASSEMBLY AND DISASSEMBLY MISC ORTHO SURGICAL INSTR LXH OBERDORF SYNTHES PRODUKTIONS GMBH 9901096 07611819534513

    Patients

    Seq Age Sex Outcome Treatment
    1