BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVIO TKA LEFT TIBIA TWIN PEG CUT GUIDE

    MDR report key: 12844206 · Received November 19, 2021

    Report

    Report Number
    3010266064-2021-00784
    Event Type
    Injury
    Date Received
    November 19, 2021
    Date of Event
    November 2, 2021
    Report Date
    December 12, 2022
    Manufacturer
    BLUE BELT TECHNOLOGIES
    Product Code
    OLO
    UDI-DI
    00885556684917
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3, H6: THE NAVIO TKA LEFT TIBIA TWIN PEG CUT GUIDE, PART NUMBER ROB00025, LOT NUMBER (10)52669, USED FOR TREATMENT WAS NOT RETURNED FOR EVALUATION. AN IMAGE WAS PROVIDED. A RELATIONSHIP BETWEEN THE REPORTED EVENT AND THE DEVICE COULD NOT BE ESTABLISHED. THE CLINICAL/MEDICAL INVESTIGATION CONCLUDED THAT BASED ON THE INFORMATION PROVIDED, THE ROOT CAUSE OF THE REPORTED EVENTS CANNOT BE DEFINITIVELY CONCLUDED. PER CASE DETAILS, ¿THE PATIENT WAS NOT HARMED BEYOND THE REPORTED¿ USE OF A DIFFERENT HOLE USED ON THE CUTTING BLOCK AND NO INJURY IS ALLEGED. ADDITIONALLY, THERE WAS NO REPORTED SURGICAL DELAY. THE PATIENT IMPACT WAS THE USE OF THE ADDITIONAL PIN HOLE NEEDED TO COMPLETE THE PROCEDURE. NO FURTHER PATIENT IMPACT CAN BE DETERMINED AND NO FURTHER CLINICAL MEDICAL ASSESSMENT IS WARRANTED. THE REPORTED PROBLEM COULD NOT BE CONFIRMED WITH A VISUAL INSPECTION. THE IMAGE PROVIDED DID NOT CONFIRM THE PINS WERE STUCK ON THE DEVICE. A COMPLAINT HISTORY REVIEW FOR SIMILAR REPORTED/CONFIRMED COMPLAINTS HAS IDENTIFIED PRIOR EVENTS. A REVIEW OF MANUFACTURING RECORDS INDICATE THE DEVICE MET ALL SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION. REFER TO THE SURGICAL TECHNIQUE GUIDE FOR KNEE ARTHROPLASTY (500197 REV C) PAGE 37, SECTION PREPARING THE BONE IN TKA, PREPARING THE TIBIA WHICH DESCRIBES THE INSTALLATION AND INSERTION OF SPEED PINS TO INSTALL. THE FAILURE MODE AND ASSOCIATED RISK HAVE BEEN ANTICIPATED WITHIN THE RISK FILE. THE RISK LEVEL IS STILL ADEQUATE. A HISTORICAL REVIEW CONCLUDED THAT NO PRIOR ESCALATION ACTIONS ARE APPLICABLE TO THE SCOPE OF THE REPORTED COMPLAINT. ALTHOUGH THE REPORTED PROBLEM WAS NOT CONFIRMED THROUGH A VISUAL OR FUNCTIONAL EVALUATION, FACTORS CONTRIBUTING TO THE REPORTED SYMPTOM MAY HAVE BEEN ASSOCIATED WITH AN IMPROPER INSERTION OF THE PINS. BASED ON THE INVESTIGATION, THE NEED FOR A CORRECTIVE ACTION IS NOT 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

    THE (B)(6). TKA LEFT TIBIA TWIN PEG CUT GUIDE, PART NUMBER ROB00025, LOT NUMBER (10)52669, USED FOR TREATMENT WAS RETURNED FOR EVALUATION. A RELATIONSHIP BETWEEN THE REPORTED EVENT AND THE DEVICE WAS ESTABLISHED. NOTHING WAS IDENTIFIED VISUALLY THAT CONTRIBUTED TO THE REPORTED PROBLEM. A FUNCTIONAL EVALUATION WAS PERFORMED. THE REPORTED PROBLEM WAS CONFIRMED. A PIN COULD NOT BE INSERTED INTO AN EXISTING PIN HOLE. AN IMAGE WAS PROVIDED. A VISUAL INSPECTION OF THE IMAGE PROVIDED DID NOT CONFIRM THE PIN WAS STUCK IN THE DEVICE. THE MOST LIKELY CAUSE OF THIS EVENT IS DUE TO DAMAGED INTERNAL SURFACE DUE TO PRIOR STUCK PIN. A REVIEW OF MANUFACTURING RECORDS INDICATE THE DEVICE MET ALL SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION. A COMPLAINT HISTORY REVIEW FOR SIMILAR REPORTED/CONFIRMED COMPLAINTS FOUND ONE SIMILAR EVENT. A HISTORICAL ESCALATION EVENT REVIEW WAS COMPLETED. A REVIEW OF PRIOR ESCALATION ACTIONS FOUND NO ACTIONS APPLICABLE TO THE SCOPE OF THE REPORTED COMPLAINT. REFER TO THE SURGICAL TECHNIQUE GUIDE FOR KNEE ARTHROPLASTY, SECTION PREPARING THE BONE IN TKA, PREPARING THE TIBIA WHICH DESCRIBES THE INSTALLATION AND INSERTION OF SPEED PINS TO INSTALL. THE FAILURE MODE AND ASSOCIATED RISK HAVE BEEN ANTICIPATED WITHIN THE RISK FILE AND THE DOCUMENTED RISK LEVEL IS STILL ADEQUATE. THE CLINICAL/MEDICAL INVESTIGATION CONCLUDED THAT BASED ON THE INFORMATION PROVIDED, THE ROOT CAUSE OF THE REPORTED EVENTS CANNOT BE DEFINITIVELY CONCLUDED. PER CASE DETAILS, ¿THE PATIENT WAS NOT HARMED BEYOND THE REPORTED¿ USE OF A DIFFERENT HOLE USED ON THE CUTTING BLOCK AND NO INJURY IS ALLEGED. ADDITIONALLY, THERE WAS NO REPORTED SURGICAL DELAY. THE PATIENT IMPACT WAS THE USE OF THE ADDITIONAL PIN HOLE NEEDED TO COMPLETE THE PROCEDURE. NO FURTHER PATIENT IMPACT CAN BE DETERMINED AND NO FURTHER CLINICAL MEDICAL ASSESSMENT IS WARRANTED. ALTHOUGH NO FURTHER CONTAINMENT OR CORRECTIVE ACTION IS RECOMMENDED OR REQUIRED AT THIS TIME, THE FAILURE MODE WILL CONTINUE TO BE CLOSELY MONITORED THROUGH COMPLAINT INVESTIGATION AND TRENDED THROUGH POST MARKET SURVEILLANCE ACTIVITIES.

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A CORI ASSISTED TKA SURGERY, THE PIN GOT STUCK IN THE NAVIO TKA LEFT TIBIA TWIN PEG CUT GUIDE. THEY WERE ABLE TO GET THE PIN OUT, BUT COULD NOT GET ANOTHER PIN TO PASS THROUGH. THEREFORE, THEY USED A DIFFERENT PIN HOLE TO ON THE BLOCK. THE PROCEDURE WAS COMPLETED, WITHOUT DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED BEYOND THE REPORTED PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1743185 NAVIO TKA LEFT TIBIA TWIN PEG CUT GUIDE ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO BLUE BELT TECHNOLOGIES ROB00025 (10)52669 00885556684917

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown