BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAMERA, POLARIS VEGA

    MDR report key: 17217999 · Received June 28, 2023

    Report

    Report Number
    3010266064-2023-00117
    Event Type
    Injury
    Date Received
    June 28, 2023
    Date of Event
    June 11, 2023
    Report Date
    July 20, 2023
    Manufacturer
    BLUE BELT TECHNOLOGIES
    Product Code
    OLO
    UDI-DI
    00885556649541
    PMA / PMN Number
    K152574
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE CAMERA, POLARIS VEGA, PART NUMBER 200597, SERIAL NUMBER (B)(6), USED FOR TREATMENT WAS NOT RETURNED FOR EVALUATION, THEREFORE A DEVICE ANALYSIS WAS UNABLE TO BE PERFORMED. A COMPLAINT HISTORY REVIEW FOR SIMILAR REPORTED/CONFIRMED COMPLAINTS CONCLUDED THIS WAS AN ISOLATED EVENT. A REVIEW OF MANUFACTURING AND SERVICE RECORDS INDICATE THE DEVICE MET ALL SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION. THE NAVIO SURGICAL TECHNIQUE GUIDE FOR KNEE ARTHROPLASTY (500197 REV C) PROVIDES GUIDELINES FOR RECOVERING TO A FULLY MANUAL PROCEDURE IN THE ¿RECOVERY PROCEDURE GUIDELINES¿. THE FAILURE MODE AND ASSOCIATED RISK HAVE BEEN ANTICIPATED WITHIN THE RISK FILE AND THE DOCUMENTED RISK LEVEL IS STILL ADEQUATE. A HISTORICAL ESCALATION EVENT REVIEW WAS NOT COMPLETED. THE PRODUCT WAS NOT RETURNED AND NO EVIDENCE WAS MADE AVAILABLE TO LINK THE COMPLAINT TO AN ESCALATION EVENT. ALTHOUGH THE REPORTED PROBLEM WAS NOT CONFIRMED THROUGH A VISUAL OR FUNCTIONAL EVALUATION, FACTORS CONTRIBUTING TO THE REPORTED SYMPTOM MAY HAVE BEEN ASSOCIATED WITH CAMERA WAS BUMPED. BASED ON THE INVESTIGATION, NO CONTAINMENT OR CORRECTIVE ACTION IS RECOMMENDED OR REQUIRED AT THIS TIME. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED THE COMPLAINT WILL BE REOPENED. THE FAILURE MODE WILL CONTINUE TO BE CLOSELY MONITORED THROUGH COMPLAINT INVESTIGATION AND TRENDED THROUGH POST MARKET SURVEILLANCE ACTIVITIES.

    Additional Manufacturer Narrative · 0

    H10: INTERNAL COMPLAINT REFERENCE (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A NAVIO-ASSISTED TKA, THE CAMERA, POLARIS VEGA DISPLAYED AN UNKNOWN ERROR MESSAGE. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, CHANGING TO MANUAL PROCEDURE INSTEAD. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1632449 CAMERA, POLARIS VEGA ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO BLUE BELT TECHNOLOGIES 00885556649541

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention ROB00043 NAVIO SURGICAL SYSTEM.