BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TROCAR WITH HANDLE FOR USE WITH 03.120.014

    MDR report key: 8339442 · Received February 14, 2019

    Report

    Report Number
    2939274-2019-56447
    Event Type
    Malfunction
    Date Received
    February 14, 2019
    Report Date
    January 25, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    FZX
    UDI-DI
    10886982074133
    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. H10 ADDITIONAL NARRATIVE: H3, H4, H6- FLOW: DEVICE INTERACTION/FUNCTIONAL. VISUAL INSPECTION: THE TROCAR WITH HANDLE FOR USE WITH 03.120.014 (PART # 03.120.015, LOT # 9921315, MFG # 20-SEP-2016) WAS RECEIVED AT US CQ WITH MINIMAL SIGNS OF WEAR. FUNCTIONAL TEST: A FUNCTIONAL TEST IS UNABLE TO BE PERFORMED SINCE THE TROCAR WITH HANDLE WAS RETURNED BY ITSELF AND THE LOCK/NEUTRAL GUIDE WAS NOT RETURNED. THE COMPLAINT WAS NOT ABLE TO BE REPLICATED. THEREFORE, THE COMPLAINT IS NOT CONFIRMED. CONCLUSION: THE COMPLAINT CONDITION IS NOT CONFIRMED AS THE TROCAR WITH HANDLE FOR USE WITH 03.120.014 (PART # 03.120.015, LOT # 9921315) WAS RECEIVED WITH MINIMAL SIGNS OF WEAR. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. WHILE NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED IT IS POSSIBLE THAT THE DEVICE ENCOUNTERED UNINTENDED FORCES. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. NO NEW MALFUNCTIONS WERE OBSERVED DURING THE COURSE OF THIS INVESTIGATION. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. DEVICE HISTORY LOT. PART: 03.120.015. LOT: 9921315. MANUFACTURING SITE: HAEGENDORF. RELEASE TO WAREHOUSE DATE: 20. SEP. 2016. 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 FUNCTIONAL, VISUAL AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURING PROCESS. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT 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 · 1

    INITIAL REPORTER IS SYNTHES SALES REPRESENTATIVE. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, AT THE STERILE DEPARTMENT PROCESSING THE TROCHAR WITH HANDLE SPRING LATCH IS WEAK AND WILL NOT LATCH ONTO LOCK/NEUTRAL GUIDE. THERE WAS NO PATIENT INVOLVEMENT. CONCOMITANT MEDICAL PRODUCTS REPORTED: LOCK/NEUTRAL GUIDE (PART #: 03.231.007, LOT #: UNKNOWN, QUANTITY #: 1). THIS REPORT IS FOR ONE (1) TROCAR WITH HANDLE FOR USE WITH 03.120.014. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133850 TROCAR WITH HANDLE FOR USE WITH 03.120.014 GUIDE FZX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.120.015 9921315 10886982074133

    Patients

    Seq Age Sex Outcome Treatment
    1 SEE EVENT DESCRIPTION.