BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVIO SOFT TISSUE PROTECTOR

    MDR report key: 10319392 · Received July 24, 2020

    Report

    Report Number
    3010266064-2020-01681
    Event Type
    Injury
    Date Received
    July 24, 2020
    Date of Event
    June 29, 2020
    Report Date
    October 7, 2022
    Manufacturer
    BLUE BELT TECHNOLOGIES
    Product Code
    OLO
    UDI-DI
    00885556628713
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    Z-1634-2020
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: THE DEVICE (PN 101092), USED IN TREATMENT, WAS RETURNED FOR INVESTIGATION. DHR REVIEW FOUND THAT NO CONDITIONS THAT COULD CONTRIBUTE TO THE REPORTED EVENT WERE FOUND. THE REPORTED PRODUCT MET MANUFACTURING SPECIFICATIONS PRIOR TO BEING RELEASED FOR DISTRIBUTION. A COMPLAINT HISTORY REVIEW FOUND SIMILAR REPORTS, THIS ISSUE WILL CONTINUE TO BE MONITORED. THE SURGICAL TECHNIQUE GUIDE (500197) PROVIDES INSTRUCTIONS FOR USING THE TISSUE PROTECTOR. THIS FAILURE IS AN IDENTIFIED FAILURE MODE WITHIN THE RISK FILE. A RELATIONSHIP BETWEEN THE REPORTED EVENT AND THE DEVICE WAS ESTABLISHED. VISUAL INSPECTION CONFIRMED THAT THE BONE PIN WAS STUCK INSIDE THE TISSUE PROTECTOR DISTAL CANULA. A FUNCTIONAL EVALUATION WAS PERFORMED AND THE LODGED BONE PINS WERE REMOVED BY FORCE. THE THREADS ON THE BONE PINS CONTAINED TISSUE, FURTHER CONFIRMING THE MALFUNCTION. THE MALFUNCTION IS DUE TO A DESIGN ISSUE DUE TO THE INNER DIAMETER OF THE TISSUE PROTECTOR LUMEN DIAMETER RELATIVE TO THE MAJOR DIAMETER OF THE BONE PIN. BINDING OF THE BONE SCREW TO THE TISSUE PROTECTOR IS PRIMARILY DUE TO TISSUE BEING WRAPPED AROUND THE THREADS. HOWEVER, INITIAL PIN MISALIGNMENT AND BENDING OF THE PIN ARE ALSO CONTRIBUTING FACTORS. A CORRECTIVE ACTION WAS OPENED AS A RESULT OF THIS ISSUE AND A NEW DESIGN AND PART NUMBER, PN 101420, HAS BEEN RELEASED. FIELD ACTIONS WERE ALSO TAKEN FOR THIS PART NUMBER DUE TO A DESIGN ISSUE. THE MEDICAL INVESTIGATION FOUND THAT: THIS COMPLAINT FROM THE UNITED STATES REPORTED THAT TWO NAVIO TISSUE PROTECTORS HAD PINS STUCK IN THEM AND COULD NOT BE USED. PER COMPLAINT DETAILS, THE ISSUE WAS FOUND PRIOR TO USE. BASED ON THE INFORMATION PROVIDED, THERE WAS NO PATIENT INJURY/IMPACT AS THE PROCEDURE WAS COMPLETED WITH MANUAL INSTRUMENTATION AND THERE WERE NO DELAYS. SMITH AND NEPHEW HAS NOT RECEIVED ADEQUATE MATERIALS TO FULLY EVALUATE THE COMPLAINT, BUT IF ADDITIONAL CLINICALLY RELEVANT MATERIALS ARE LATER RECEIVED, THEN THE CASE MAY BE RE-OPENED FOR FURTHER EVALUATION. INTERNAL COMPLAINT REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    THE DEVICE, USED IN TREATMENT, WAS RETURNED FOR INVESTIGATION. DHR REVIEW FOUND THAT NO CONDITIONS THAT COULD CONTRIBUTE TO THE REPORTED EVENT WERE FOUND. THE REPORTED PRODUCT MET MANUFACTURING SPECIFICATIONS PRIOR TO BEING RELEASED FOR DISTRIBUTION. A COMPLAINT HISTORY REVIEW FOUND SIMILAR REPORTS, THIS ISSUE WILL CONTINUE TO BE MONITORED. THE SURGICAL TECHNIQUE GUIDE (500197) PROVIDES INSTRUCTIONS FOR USING THE TISSUE PROTECTOR. THIS FAILURE IS AN IDENTIFIED FAILURE MODE WITHIN THE RISK FILE. WE WERE ABLE TO CONFIRM IF THERE WAS A RELATIONSHIP ESTABLISHED BETWEEN THE REPORTED EVENT AND THE DEVICE. VISUAL INSPECTION CONFIRMED THAT THE BONE PIN WAS STUCK INSIDE THE TISSUE PROTECTOR DISTAL CANULA. A FUNCTIONAL EVALUATION WAS PERFORMED AND THE LODGED BONE PINS WERE REMOVED BY FORCE. THE THREADS ON THE BONE PINS CONTAINED TISSUE, FURTHER CONFIRMING THE MALFUNCTION. THE MALFUNCTION IS DUE TO A DESIGN ISSUE DUE TO THE INNER DIAMETER OF THE TISSUE PROTECTOR LUMEN DIAMETER RELATIVE TO THE MAJOR DIAMETER OF THE BONE PIN. BINDING OF THE BONE SCREW TO THE TISSUE PROTECTOR IS PRIMARILY DUE TO TISSUE BEING WRAPPED AROUND THE THREADS. HOWEVER, INITIAL PIN MISALIGNMENT AND BENDING OF THE PIN ARE ALSO CONTRIBUTING FACTORS. A CORRECTIVE ACTION WAS OPENED AS A RESULT OF THIS ISSUE AND A NEW DESIGN AND PART NUMBER, PN: 101420, HAS BEEN RELEASED. THE MEDICAL INVESTIGATION FOUND THAT THIS COMPLAINT FROM THE UNITED STATES REPORTED THAT THE NAVIO TISSUE PROTECTOR HAD A PIN STUCK IN IT AND COULD NOT BE USED. PER COMPLAINT DETAILS, THE ISSUE WAS FOUND PRIOR TO USE. BASED ON THE INFORMATION PROVIDED, THERE WAS NO PATIENT INJURY/IMPACT AS THE PROCEDURE WAS COMPLETED WITH MANUAL INSTRUMENTATION AND THERE WERE NO DELAYS. SMITH AND NEPHEW HAS NOT RECEIVED ADEQUATE MATERIALS TO FULLY EVALUATE THE COMPLAINT, BUT IF ADDITIONAL CLINICALLY RELEVANT MATERIALS ARE LATER RECEIVED, THEN THE CASE MAY BE RE-OPENED FOR FURTHER EVALUATION. OUR REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE, TWO NAVIO SOFT TISSUE PROTECTORS HAD A BONE PIN STUCK AND THERE ARE DIFFICULT TO SEPARATE. THE PROCEDURE WAS CONTINUED WITH MANUAL INSTRUMENTATION AND THERE WERE NO DELAYS. NO OTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    784759 NAVIO SOFT TISSUE PROTECTOR ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO BLUE BELT TECHNOLOGIES 00885556628713

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention