BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T-PLIF 10MM TRIAL SPACER 8MM HEIGHT

    MDR report key: 9144647 · Received October 2, 2019

    Report

    Report Number
    2939274-2019-61088
    Event Type
    Malfunction
    Date Received
    October 2, 2019
    Report Date
    September 5, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HWT
    UDI-DI
    10705034722993
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. UPDATED CATALOG NUMBER 03.806.008. 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 · 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 03.806.008, LOT H210967: RELEASE TO WAREHOUSE DATE: JANUARY 14, 2017. SUPPLIER: (B)(4) . NO NON-CONFORMANCE REPORTS (NCR'S) WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUB-COMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A PRODUCT INVESTIGATION WAS COMPLETED: UPON VISUAL INSPECTION, IT IS OBSERVED THAT THE DEVICE WAS SPOT WELDED ON TWO SPOTS (UNINTENDED MODIFICATION). THE DEVICE WAS MODIFIED IN A NON DEPUYSYNTHES FACILITY. THE REST OF THE DEVICE SHOWS NORMAL WEAR WHICH WOULD NOT CONTRIBUTE TO THE COMPLAINT CONDITION. THUS, THE REPORTED COMPLAINT IS CONFIRMED. THE RELEVANT DRAWINGS WERE REVIEWED DURING THE INVESTIGATION; NO DESIGN ISSUES OR DISCREPANCIES WERE NOTED DURING THE INVESTIGATION. THE COMPLAINT IS CONFIRMED. DEFINITIVE ROOT CAUSE FOR THE REPORTED COMPLAINT IS THE DEVICE WAS MODIFIED IN A NON-DEPUY SYNTHES FACILITY. NO PRODUCT DESIGN OR MANUFACTURING ISSUES WERE IDENTIFIED, AND NO NEW MALFUNCTIONS WERE IDENTIFIED EITHER. BASED UPON THESE RESULTS, NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. 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

    THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. (B)(4) SUSPECT ADULTERATED AND REVIEW REQUIRED: NEW REPORTABLE MALFUNCTION IDENTIFIED. 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) 2019 THE SALES CONSULTANT TOOK HAMMERS AND TRIAL SHAFTS TO BE WELDED AT A LOCAL MACHINE SHOP PER THE SURGEON¿S INSTRUCTIONS. THE INSTRUMENTS WERE SPOT WELDED TWICE, ABOUT 180 DEGREES OFFSET AND NOT A CIRCUMFERENTIAL WELD. THE SURGEON¿S PRACTICE IS TO USE A GENERAL SURGICAL HAMMER TO INSERT AND REMOVE THE TRIAL. WHEN THE TRIALS ARE HAMMED OUT FOR REMOVAL, THE SURGEON HITS THE UNDERSIDE OF THE DEVICE WHERE THE COLLAR IS TO ENABLE THE RELEASE OF THE TRIAL SHAFT AS PART OF ITS MODULAR DESIGN. DURING THE REMOVAL THE TRIAL WOULD DETACH FROM THE T-HANDLE WHEN SURGEON WOULD HIT THE COLLAR OF T-HANDLE AS HE WAS REMOVING THE TRIAL FROM THE DISC SPACE WITH THE HOSPITAL MALLET. THE DEVICES WERE RETURNED TO THE SURGEON AFTER (B)(6) 2019 AND WERE STERILIZED. THE MODIFIED INSTRUMENTS WERE USED IN TEN (10) CASES. THE INSTRUMENTS WERE REMOVED FROM THE FACILITY ON (B)(6) 2019. THERE WERE NO ADVERSE EVENTS, DELAYS, MALFUNCTIONS, FRAGMENTS, OR OTHER MEDICAL INTERVENTIONS. THIS COMPLAINT INVOLVES TWENTY-ONE (21) DEVICES. THIS REPORT IS FOR ONE (1) T-PLIF 10MM TRIAL SPACER 8MM HEIGHT. THIS IS REPORT 4 OF 10 FOR (B)(4). THIS COMPLAINT IS LINKED TO (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    939964 T-PLIF 10MM TRIAL SPACER 8MM HEIGHT TEMPLATE HWT WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.806.008 H210967 10705034722993

    Patients

    Seq Age Sex Outcome Treatment
    1