BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TROCAR WITH HANDLE FOR USE WITH 03.120.014

    MDR report key: 10567934 · Received September 22, 2020

    Report

    Report Number
    2939274-2020-04246
    Event Type
    Malfunction
    Date Received
    September 22, 2020
    Date of Event
    August 27, 2020
    Report Date
    August 27, 2020
    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
    KS, US
    Reporter Occupation
    PHYSICIAN

    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. H3, H4, H6: PART: 03.120.015. LOT: 8102227. MANUFACTURING SITE: HÄGENDORF. RELEASE TO WAREHOUSE DATE: JANUARY 08, 2013. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. VISUAL INSPECTION: THE TROCAR WITH HANDLE FOR USE WITH 03.120.014 WAS RECEIVED AT US CUSTOMER QUALITY (CQ). UPON VISUAL INSPECTION IT WAS NOTICED THERE WERE NO DEFECTS ON THE DEVICE ITSELF. FUNCTIONAL TEST: FUNCTIONAL TEST WAS NOT PERFORMED AS THE MATING DEVICE WAS NOT RETURNED. THE COMPLAINT REPLICATION IS UNABLE TO BE PERFORMED WITH THE RETURNED DEVICES. TROCAR OD = CONFORMING. DOCUMENT/ SPECIFICATION REVIEW: CURRENT AND MANUFACTURED REVISIONS WERE REVIEWED. NO DESIGN ISSUES OR DISCREPANCIES WERE IDENTIFIED. INVESTIGATION CONCLUSION: THE COMPLAINT CANNOT BE CONFIRMED AS THE MATING DEVICE(S) WERE NOT RECEIVED. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED BASED ON THE PROVIDED INFORMATION. NO NEW, UNIQUE, OR DIFFERENT PATIENT HARMS WERE IDENTIFIED AS A RESULT OF THIS EVALUATION. 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 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 HAS BEEN 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 (B)(6) 2020, THE TROCAR HANDLE IS NOT HOLDING TROCARS LIKE IT SHOULD BE. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCES REPORTED. 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
    1032984 TROCAR WITH HANDLE FOR USE WITH 03.120.014 GUIDE, SURGICAL, INSTRUMENT FZX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.120.015 8102227 10886982074133

    Patients

    Seq Age Sex Outcome Treatment
    1