BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTECTION SLEEVE FOR FNS INSERTION INSTRUMENTS

    MDR report key: 12393521 · Received August 31, 2021

    Report

    Report Number
    2939274-2021-05067
    Event Type
    Malfunction
    Date Received
    August 31, 2021
    Report Date
    July 6, 2021
    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
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: PART #: 03.168.013; LOT #: 170413-205; SUPPLIER LOT #: 170413-205; RELEASE TO WAREHOUSE DATE: MAY 25, 2018; SUPPLIER: (B)(4); NO NCR'S 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. VISUAL INSPECTION: THE PROTECTION SLEEVE FOR FNS INSERTION INSTRUMENTS (PART # 03.168.013 / LOT # 170413-205) WAS RECEIVED AT US CUSTOMER QUALITY (CQ). UPON VISUAL INSPECTION, THE DISTAL TIP OF THE DEVICE WAS FOUND TO BE DEFORMED/BENT OUTWARD. ADDITIONALLY, THERE WERE SCRATCHES ON THE DEVICE WHICH DO NOT AFFECT THE FUNCTIONALITY OF THE DEVICE. NO OTHER DEFECTS WERE OBSERVED WITH THE RETURNED DEVICE. DEVICE FAILURE/DEFECT IDENTIFIED? YES. DIMENSIONAL INSPECTION: SPECIFIED DIMENSIONS: DISTAL TIP OD. MEASURED DIMENSIONS: DISTAL TIP OD (BEFORE BEND) = CONFORMING DEVICE USED - CALIPER. DOCUMENT/SPECIFICATION REVIEW: THE FOLLOWING CURRENT AND MANUFACTURED REVISIONS WERE REVIEWED: MANUFACTURED AND CURRENT REVISIONS. COMPLAINT CONFIRMED? YES. INVESTIGATION CONCLUSION: THIS COMPLAINT IS CONFIRMED AS THE DISTAL TIP OF THE DEVICE WAS DEFORMED OUTWARD. NO DEFINITIVE ROOT-CAUSE CAN BE DETERMINED BASED ON THE PROVIDED INFORMATION. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, A DAMAGED TROCHAR AND FNS FELL ON THE FLOOR DURING AN UNKNOWN PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) PROTECTION SLEEVE FOR FNS INSERTION INSTRUMENTS. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1297901 PROTECTION SLEEVE FOR FNS INSERTION INSTRUMENTS CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY GEA WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.168.013 170413-205 10886982274441

    Patients

    Seq Age Sex Outcome Treatment
    1