BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T-PLIF IMPLANT HOLDER

    MDR report key: 7999754 · Received October 24, 2018

    Report

    Report Number
    2939274-2018-54570
    Event Type
    Malfunction
    Date Received
    October 24, 2018
    Date of Event
    October 8, 2018
    Report Date
    October 9, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    GEN
    UDI-DI
    10705034775210
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    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. PART 389.266, LOT A7QA05: RELEASE TO WAREHOUSE DATE: JULY 31, 2007. MANUFACTURE SITE: TUTTLINGEN. THERE WERE TWO MANUFACTURING BATCHES USING THIS LOT NUMBER. ONE WAS 912591 AND THE OTHER WAS 912418. A REVIEW OF THE BOTH DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES AT THE TIME OF MANUFACTURING OF THIS DEVICE AND ITS SUB COMPONENTS THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. THE REVIEW OF RAW MATERIAL CERTIFICATE COULD NOT BE CARRIED OUT, BECAUSE IT IS NOT AVAILABLE. NO NON-CONFORMANCE REPORTS (NCRS) WERE GENERATED DURING THE PRODUCTION OF THIS DEVICE. REVIEW OF THE DEVICE HISTORY RECORD OF TUTTLINGEN SHOWED THAT THERE WERE NO ISSUES AT THE TIME OF MANUFACTURING OF THIS DEVICE THAT WOULD CONTRIBUTE TO THE ISSUE OUTLINED IN THIS COMPLAINT. A PRODUCT INVESTIGATION WAS COMPLETED: THE RETURNED INSTRUMENT WAS EXAMINED AND THE DISTAL TIP ON THE LOWER JAW HAS BROKEN OFF AND WAS NOT RETURNED. THE BALANCE OF THE DEVICE IS IN FAIR CONDITION. THE RECEIVED CONDITION DOES AGREE WITH THE COMPLAINT DESCRIPTION AND IS CONFIRMED. THE CAUSE OF THE ISSUE COULD NOT BE DETERMINED TO BE USE ERROR, MISUSE/ABUSE, NONCOMPLIANCE, OR POST-OPERATIVE TRAUMA. DIMENSIONAL ANALYSIS COULD NOT BE PERFORMED THE BROKEN TIP WAS NOT RETURNED AND DUE TO THE POST MANUFACTURING DAMAGE OF THIS ELEVEN (11) YEAR DEVICE. THE RELEVANT DRAWINGS WERE REVIEWED. A DESIGN CHANGE FOR THE LOWER JAW WAS INITIATED WHERE THE RADIUS NEAR THE DISTAL TIP WAS ADJUSTED TO IMPROVE THE PERFORMANCE AGAINST BREAKING AT THE SUSPECT AREA. THE RETURNED DEVICE WAS MANUFACTURING PRIOR TO THE DESIGN CHANGE. A DEVICE HISTORY REVIEW, WAS PERFORMED FOR THE RETURNED INSTRUMENT¿S LOT NUMBER, NO NON-CONFORMANCE REPORTS (NCRS) AND NO MATERIAL REVIEW REPORTS (MRRS) OR COMPLAINT-RELATED ISSUES WERE IDENTIFIED WITH THE LOT NUMBER WHICH MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. THE REVIEW OF RAW MATERIAL CERTIFICATE COULD NOT BE CARRIED OUT, BECAUSE IT IS NOT AVAILABLE. HOWEVER, SINCE THE DEVICE THE IS 11 YEARS OLD IT IS NOT BELIEVED THIS CONTRIBUTED TO THE COMPLAINT CONDITION. WHILE NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED IT IS POSSIBLE THAT THE AGE OF THE DEVICE AND ANY UNINTENDED FORCES ENCOUNTERED DURING USAGE OR HANDLING COULD HAVE CONTRIBUTED TO BE COMPLAINT CONDITION. DURING THE INVESTIGATION, NO PRODUCT DESIGN OR MANUFACTURING ISSUES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED.

    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. DEVICE EVALUATED BY MFR: A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. 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

    COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. INITIAL REPORTER IS SYNTHES SALES REPRESENTATIVE. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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

    IT WAS REPORTED THAT ON (B)(6) 2018 A PATIENT UNDERWENT POSTERIOR SPINAL FUSION WHEN THE T-PLIF IMPLANT HOLDER BROKE INTRA-OPERATIVELY. IT IS UNKNOWN IF THERE WERE FRAGMENTS FROM THE DEVICE. THERE WAS NO PATIENT CONSEQUENCE. THE PROCEDURE OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) T-PLIF IMPLANT HOLDER. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839325 T-PLIF IMPLANT HOLDER FORCEPS,GEN & PLASTIC SURGERY GEN WRIGHTS LANE SYNTHES USA PRODUCTS LLC 389.266 A7QA05 10705034775210

    Patients

    Seq Age Sex Outcome Treatment
    1