BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6.2MM TI CLICK'X® PEDICLE SCR PREASSEMBLED 35MM THRD LENGTH

    MDR report key: 7952647 · Received October 10, 2018

    Report

    Report Number
    8030965-2018-57183
    Event Type
    Malfunction
    Date Received
    October 10, 2018
    Date of Event
    September 24, 2018
    Report Date
    September 24, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    MNH
    UDI-DI
    07611819143975
    PMA / PMN Number
    K082572
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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. DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART: 498.987, LOT: 8780736. MANUFACTURING LOCATION: MEZZOVICO, RELEASE TO WAREHOUSE DATE: DEC 19, 2013. THE DEVICE HISTORY RECORD SHOWS THIS LOT WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURING PROCESS. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. PRODUCT INVESTIGATION WAS COMPLETED. TWO PHOTOGRAPHS WERE PROVIDED WITH A SINGLE POLYAXIAL HEAD IN EACH. THE PEDICLE SCREW WAS NOT ASSEMBLED WITH THE HEAD IN THE PICTURES. IT CANNOT BE CONFIRMED WHICH OF THE TWO SCREWS ON THIS COMPLAINT IS REPRESENTED IN THE PHOTOGRAPHS. THE PRODUCT CODE AND LOT NUMBER WERE NOT LEGIBLE IN THE PHOTOGRAPH SHOWING THE SIDE OF ONE OF THE POLYAXIAL HEADS. THE OTHER PHOTOGRAPH SHOWED THE INTERIOR OF ONE OF THE POLYAXIAL HEADS, WHICH INDICATED COSMETIC WEAR OF THE ANODIZATION LAYER AROUND THE TOP OF THE INTERIOR (WHICH INTERACTS WITH THE LOCKING CAP) AND DEFORMATION OF THE FEATURES AT THE BOTTOM (WHICH INTERACT WITH THE PEDICLE SCREW). NO ADDITIONAL VIEWS OF THE DEVICE WERE PROVIDED. DUE TO THE OBSERVED CONDITION AND THE INABILITY TO IDENTIFY THE DEVICE DEPICTED IN THE PHOTOGRAPHS PROVIDED, THE COMPLAINT CONDITION IS BEING CONFIRMED FOR BOTH SCREWS WITH THE PICTURES PROVIDED. THE COMPLAINT CONDITION WAS CONFIRMED WITH INVESTIGATION PERFORMED WITH THE PHOTOGRAPHS PROVIDED. NO DESIGN OR MANUFACTURING DEFECT OR DEFICIENCY WAS OBSERVED DURING THE INVESTIGATION. NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED AS THE CIRCUMSTANCES SURROUNDING THE EVENT ARE UNKNOWN. IF ADDITIONAL INFORMATION IS RECEIVED, AN ASSESSMENT OF THIS ADDITIONAL INFORMATION WILL BE PERFORMED. THE COMPLAINT CONDITION WAS CONFIRMED WITH INVESTIGATION PERFORMED WITH THE PHOTOGRAPHS PROVIDED. NO DESIGN OR MANUFACTURING DEFECT OR DEFICIENCY WAS OBSERVED DURING THE INVESTIGATION. NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED AS THE CIRCUMSTANCES SURROUNDING THE EVENT ARE UNKNOWN. IF ADDITIONAL INFORMATION IS RECEIVED, AN ASSESSMENT OF THIS ADDITIONAL INFORMATION WILL BE PERFORMED. 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

    ADDITIONAL DEVICE PRODUCT CODES: MNI, NKB, KWP, KWQ. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 DURING AN UNKNOWN PROCEDURE ON (B)(6) 2018, THE TIP OF THE RATCHET T-HANDLE THAT CONNECTS TO THE T-CABLE DOES NOT QUITE FIT THE SCREW HEAD, AND IT WAS ALSO NOTED THAT WHEN TURNING THE RATCHET, THE SCREW HEAD ENDS UP DUSTING. THE PATIENT WITH SPINE FRACTURE WAS REQUIRED TO HAVE A FIXATION OF 14 SCREWS BUT DUE TO THE ISSUE ENCOUNTERED, THE SURGEON WAS ONLY ABLE TO PASS 2 PEDICLE SCREWS IN THE SPINE WHICH ARE NOT FULLY FIXED. SURGEON COULD NOT PUT THE REST OF THE SCREWS OR REMOVE THE ONES THAT WERE ALREADY PUT IN. ACCORDING TO THE TECHNICAL ASSISTANT THE ISSUE HAD ALREADY HAPPENED (CAPTURED UNDER COMPLAINT (B)(4)), AND THEY ALREADY ASKED FOR A REPLACEMENT BUT WAS NOT SURE IF THE REPLACEMENT WAS MADE. THE PROCEDURE WAS NOT COMPLETED, PATIENT STATUS WAS SEVERE, EXPERIENCING FEVER DURING THE SURGERY WHICH MAY INDICATE AN INFECTION PROCESS. THE PATIENT UNDERWENT ANOTHER SURGERY ON (B)(6) 2018 TO REMOVE THE TWO SCREWS AND WAS IMPLANTED WITH THE EXPEDIUM MATERIAL. DURING THE REVISION SURGERY THE SURGEON TESTED THE KEY THAT HAD BEEN USED IN THE FIRST SURGERY AND A NEW ONE. STILL THE BOLT DID NOT LEAVE THE PATIENT. IT WAS NECESSARY TO PERFORM ANOTHER TECHNIQUE TO EXTRACT ONE OF THE BOLTS AND THE OTHER BOLT CAME OUT NORMALLY WITH THE WRENCH. BOTH THE SCREWS WERE REMOVED SUCCESSFULLY. PER SALES CONSULTANT, APPARENTLY, THE PROBLEM WAS THE HEAD OF THE SCREW THAT DUSTED, AND THE KEY DID NOT PRESENT A PROBLEM. REVISION SURGERY WAS COMPLETED SUCCESSFULLY. CONCOMITANT DEVICE: RATCHET T-HANDLE 6MM HXC (PART # 388.652, LOT # H527141, QUANTITY 1). THIS REPORT IS FOR ONE (1) 6.2MM TI CLICK'X PEDICLE SCREW. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795108 6.2MM TI CLICK'X® PEDICLE SCR PREASSEMBLED 35MM THRD LENGTH ORTHOSIS, SPONDYLOSTHESIS, SPINAL FIXATION MNH OBERDORF SYNTHES PRODUKTIONS GMBH 8780739 07611819143975

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR