BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGLED TI TOP LOADING TRANSCONNECTOR/MED

    MDR report key: 12806866 · Received November 12, 2021

    Report

    Report Number
    2939274-2021-06686
    Event Type
    Malfunction
    Date Received
    November 12, 2021
    Report Date
    October 19, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    MNI
    UDI-DI
    10705034739427
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #: (B)(4). 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: H3, H6: A PRODUCT INVESTIGATION WAS CONDUCTED. VISUAL INSPECTION: THE COMPLAINT DEVICE ANGLED TI TOP LOADING TRANSCONNECTOR/MED (PRODUCT CODE: 04.614.551, LOT NUMBER: 9981459) WAS RETURNED TO CQ WEST CHESTER FOR INVESTIGATION. THE FEMALE LINK AND MALE LINK OF THE TRANS CONNECTOR WAS RETURNED SEPARATED FROM. NO OTHER ISSUES WERE IDENTIFIED. FUNCTIONAL TEST: THE LINKS SHOULD NOT COME OFF OF THE CONNECTION EVEN WHEN IT IS NOT LOCKED. WHEN THEY WERE PUT TOGETHER THERE WAS A LOOSE FIT AND THE MALE LINK CAME OFF OF THE CONNECTION IF IT IS NOT LOCKED USING THE BUSHING. THE COMPLAINT CAN BE REPLICATED DURING EVALUATION. DIMENSIONAL INSPECTION: A DIMENSIONAL INSPECTION COULD NOT BE PERFORMED DUE TO THE DESIGN OF THE DEVICE. DOCUMENT/SPECIFICATION REVIEW: BASED ON THE DATE OF MANUFACTURE, THE CURRENT AND MANUFACTURED TO VERSION OF DRAWING WERE REVIEWED. YES, THE COMPLAINT CONDITION CAN BE CONFIRMED DURING PHYSICAL DEVICE INVESTIGATION. CONCLUSION: THE TRANS CONNECTOR LINKS WAS RETURNED SEPARATED. IT IS NOT CLEAR AS TO WHAT CAUSED THIS ISSUE AND A DEFINITIVE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. 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. H3, H4, H6: A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PART # 04.614.551; SYNTHES LOT # 9981459; SUPPLIER LOT # N/A; RELEASE TO WAREHOUSE DATE: 12 JAN 2016; MANUFACTURED BY: SYNTHES ELMIRA. NO NCRS 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. 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

    ADDITIONAL PRODUCT CODE: NKG, KWP, MNH. 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 · 0

    IT WAS REPORTED THAT, DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT (B)(6) THE ANGLED TI TOP LOADING TRANS CONNECTOR/ MED WAS FOUND BROKEN. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) ANGLED TI TOP LOADING TRANSCONNECTOR/ MED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1700288 ANGLED TI TOP LOADING TRANSCONNECTOR/MED ORTHOSIS, SPINAL PEDICLE FIXATION MNI WRIGHTS LANE SYNTHES USA PRODUCTS LLC 04.614.551 9981459 10705034739427

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown