BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVIO BBT FOOTPEDAL

    MDR report key: 11617630 · Received April 6, 2021

    Report

    Report Number
    3010266064-2021-00262
    Event Type
    Injury
    Date Received
    April 6, 2021
    Date of Event
    March 11, 2021
    Report Date
    November 16, 2021
    Manufacturer
    BLUE BELT TECHNOLOGIES
    Product Code
    OLO
    PMA / PMN Number
    K152574
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3, H6: THE NAVIO SURGICAL SYSTEM (AUSTRALIA) PRODUCT NPFS02070, SN (B)(6) INTENDED FOR USE IN TREATMENT WAS NOT MADE AVAILABLE TO THE DESIGNATED COMPLAINT UNIT FOR EVALUATION; THUS, A VISUAL AND FUNCTIONAL EVALUATION COULD NOT BE PERFORMED, AND A RELATIONSHIP BETWEEN THE REPORTED EVENT AND THE DEVICE COULD NOT BE DETERMINED. A REVIEW OF MANUFACTURING AND SERVICE RECORDS INDICATE THE DEVICE MET ALL SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION. A COMPLAINT HISTORY REVIEW FOR SIMILAR REPORTED/CONFIRMED COMPLAINTS HAS IDENTIFIED PRIOR EVENTS. ALTHOUGH THE REPORTED PROBLEM WAS NOT CONFIRMED, A FACTOR THAT MAY HAVE CONTRIBUTED TO THE REPORTED SYMPTOM MAY BE ASSOCIATED WITH A BROKEN PIN IN THE PLUG. THE NAVIO SURGICAL TECHNIQUE GUIDE FOR KNEE ARTHROPLASTY PROVIDES GUIDELINES FOR RECOVERING TO A FULLY MANUAL PROCEDURE IN THE ¿RECOVERY PROCEDURE GUIDELINES¿. THIS FAILURE MODE IS IDENTIFIED IN THE RISK PROFILE. PER COMPLAINT DETAILS FROM AUSTRALIA, IT WAS REPORTED THAT BEFORE A NAVIO TKA PROCEDURE, THE ANSPACH FOOTPEDAL WOULD NOT CONNECT. AFTER FURTHER INSPECTION, A BROKEN PIN IN THE PLUG WAS FOUND. BASED ON THE INFORMATION PROVIDED, THE PROCEDURE WAS CONTINUED WITH MANUAL INSTRUMENTATION. NO PATIENT INJURY, IMPACT OR COMPLICATIONS WERE REPORTED. SMITH & NEPHEW HAS NOT RECEIVED ADEQUATE MATERIALS (OPERATIVE REPORTS) TO FULLY EVALUATION THE COMPLAINT, BUT IF ADDITIONAL CLINICALLY RELEVANT MATERIALS ARE LATER RECEIVED THE COMPLAINT CAN BE REOPENED. ALTHOUGH NO FURTHER CONTAINMENT OR CORRECTIVE ACTION IS RECOMMENDED OR REQUIRED AT THIS TIME, ALL COMPLAINTS ARE MONITORED AND TRENDED THROUGH POST MARKET SURVEILLANCE ACTIVITIES. IF THE PRODUCT ASSOCIATED WITH THIS EVENT IS RETURNED AT A FUTURE DATE, THIS EVALUATION WILL BE REOPENED FOR INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE A NAVIO TKA PROCEDURE, IT WAS NOTICED THAT THE ANSPACH FOOTPEDAL WOULD NOT CONNECT. AFTER FURTHER INSPECTION, A BROKEN PIN IN THE PLUG WAS FOUND. THE PROCEDURE WAS CONTINUED WITH MANUAL INSTRUMENTS. NO OTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518586 NAVIO BBT FOOTPEDAL ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO BLUE BELT TECHNOLOGIES

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R| O