BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5MM TI CURVED ROD 80MM

    MDR report key: 12811528 · Received November 15, 2021

    Report

    Report Number
    2939274-2021-06694
    Event Type
    Malfunction
    Date Received
    November 15, 2021
    Report Date
    October 19, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    NKG
    UDI-DI
    10705034788982
    PMA / PMN Number
    K142838
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6). THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, 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 · 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. H10 ADDITIONAL NARRATIVE: H6 - CODES UPDATED TO IMDRF CODES. VISUAL INSPECTION: THE COMPLAINT DEVICE 3.5MM TI CURVED ROD 80MM (PRODUCT CODE: 498.137, LOT NUMBER: 9943959) WAS RETURNED TO CQ WEST CHESTER FOR INVESTIGATION. THE TI ROD WAS BROKEN. THE REMAINING BROKEN PARTS WERE NOT RETURNED FOR INVESTIGATION. DOCUMENT /SPECIFICATION REVIEW: BASED ON THE DATE OF MANUFACTURE, THE CURRENT AND MANUFACTURED VERSION OF THE DRAWINGS WERE REVIEWED. CONCLUSION: THE ROD WAS RETURNED BROKEN FOR INVESTIGATION. A DEFINITIVE ROOT CAUSE WAS NOT DETERMINED DURING INVESTIGATION. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. NO DESIGN ISSUES WERE OBSERVED DURING THE DOCUMENT/SPECIFICATION REVIEW. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT 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 HISTORY LOT - A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE 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 · 0

    IT WAS REPORTED THAT ON (B)(6) 2021, ONE 3.5MM TITANIUM ROD AND ONE 3.5MM TITANIUM CURVED ROD WAS FOUND TO BE BROKEN DURING THE REVERSE LOGISTICS AUDIT OF THE RETURNED DEVICE AT (B)(4). THERE WAS NO PATIENT INVOLVEMENT, AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 3.5MM TI CURVED ROD 80MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1715147 3.5MM TI CURVED ROD 80MM POSTERIOR CERVICAL SCREW SYSTEM NKG WRIGHTS LANE SYNTHES USA PRODUCTS LLC 498.137 9943959 10705034788982

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown 3.5MM TI ROD 240MM