BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTECTION SLEEVE FOR FNS INSERTION INSTRUMENTS

    MDR report key: 10795388 · Received November 5, 2020

    Report

    Report Number
    2939274-2020-04985
    Event Type
    Malfunction
    Date Received
    November 5, 2020
    Date of Event
    October 10, 2020
    Report Date
    October 10, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    GEA
    UDI-DI
    10886982274441
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHESE IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHESE HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHESE OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHESE, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H10 ADDITIONAL NARRATIVE: B3: UPDATED EVENT DATE B5: UPDATED EVENT DESCRIPTION H3, H6: A PRODUCT INVESTIGATION WAS CONDUCTED: INVESTIGATION FLOW: DAMAGE VISUAL INSPECTION: THE PROTECTION SLEEVE FOR FNS INSERTION INSTRUMENTS (PART # 03.168.013 / LOT # 180242-301) WAS RECEIVED AT US CQ. THE DISTAL TIP OF THE DEVICE WAS DEFORMED/BENT INWARD. NO ADDITIONAL DEFECTS WERE OBSERVED ON THE COMPLAINT DEVICE. DEVICE FAILURE/DEFECT WAS IDENTIFIED. DOCUMENT/SPECIFICATION REVIEW: NO DESIGN ISSUES OR DISCREPANCIES WERE IDENTIFIED. INVESTIGATION CONCLUSION: THIS COMPLAINT IS CONFIRMED AS THE DISTAL TIP OF THE DEVICE WAS DEFORMED INWARD. 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 HISTORY LOT PART: 03.168.013 LOT: 180242-301 MANUFACTURING SITE: SELZACH SUPPLIER: LEITNER AG RELEASE TO WAREHOUSE DATE: DECEMBER 07, 2018 A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCE'S 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

    UPDATED EVENT DESCRIPTION: IT WAS REPORTED THAT ON (B)(6) 2020, THE DISTAL TIP OF THE PROTECTION SLEEVE FOR FNS INSERTION INSTRUMENTS WAS BENT WHEN THE TRAY WAS OPENED BEFORE THE SURGERY. THIS COMPLAINT INVOLVES ONE (1) DEVICE.

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER: (B)(6). THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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, THE TIP OF THE PROTECTION SLEEVE FOR FEMORAL NECK SYSTEM (FNS) INSERTION INSTRUMENTS WAS BENT WHEN THE TRAY WAS OPENED BEFORE THE SURGERY. THIS REPORT IS FOR 1 PROTECTION SLEEVE FOR FNS INSERTION INSTRUMENTS. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1255599 PROTECTION SLEEVE FOR FNS INSERTION INSTRUMENTS CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY GEA WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.168.013 180242-301 10886982274441

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR