BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CANN H.F. DGNST 6MM RTBL DBL VLV

    MDR report key: 13009310 · Received December 15, 2021

    Report

    Report Number
    1219602-2021-02715
    Event Type
    Injury
    Date Received
    December 15, 2021
    Date of Event
    November 9, 2021
    Report Date
    May 18, 2022
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    NBH
    UDI-DI
    03596010573520
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10: INTERNAL COMPLAINT REFERENCE: (B)(4). H6: THE REPORTED DEVICE WAS NOT RETURNED TO THE DESIGNATED COMPLAINT UNIT FOR INDEPENDENT EVALUATION, THUS VISUAL INSPECTION AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. IT WAS DETERMINED THE DEVICE DID NOT CONTRIBUTE TO THE REPORTED EVENT. A COMPLAINT HISTORY REVIEW CONCLUDED THIS WAS AN ISOLATED EVENT. A REVIEW OF DEVICE RECORDS SHOWED THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATION UPON RELEASE FOR DISTRIBUTION. THE INSTRUCTIONS FOR USE WAS REVIEWED AND FOUND TO INCLUDE CONDITIONS OF OFF LABEL USE AND TECHNIQUE SPECIFICS, AS WELL AS PRECAUTIONS AND WARNINGS RELATED TO THE USE OF THE DEVICE. A RISK MANAGEMENT REVIEW FOUND THAT THE REPORTED FAILURE WAS DOCUMENTED APPROPRIATELY, AND THERE WERE NO INDICATIONS TO SUGGEST THE ANTICIPATED RISK IS NOT ADEQUATE. A REVIEW OF THE CUSTOMER PROVIDED IMAGES FOUND THE DEVICE BEING HANDLED AND A DARK SUBSTANCE AROUND THE OPENING OF THE CANNULA AND THE O-RING SEAL. THE IDENTITY OF THE SUBSTANCE CANNOT BE DETERMINED THROUGH THE IMAGES. IT WAS REPORTED THE SURGEON REQUESTED A SWAB OF THE INSIDE OF THE CANNULA FOR CULTURES THAT WAS SENT TO THE PATHOLOGY LAB FOR TESTING SINCE THE INSTRUMENTS WERE USED INSIDE OF THE PATIENT¿S JOINT. SUBSEQUENTLY, IT WAS REPORTED THE SURGEON ORDERED ANTIBIOTICS IN THE SOLUTIONS. IT WAS REPORTED THE SURGEON REPORTED ANOTHER SET OF TWEEZERS AND LENS TO CONCLUDE THE PROCEDURE WITH A NON-SIGNIFICANT DELAY. ALTHOUGH THE SURGEON INDICATED HE APPLIED ANTIBIOTICS TO THE INNER CANULA WHICH WAS IN THE JOINT CAVITY, THE PATIENT WAS POTENTIALLY EXPOSED TO THIS UNIDENTIFIED BLACK SUBSTANCE. AT THE END OF THE PROCEDURE, IT WAS NOTICED SOME WEAR OF THE COVERING AND THE LENS. HOWEVER, THE POTENTIAL FOR ADVERSE SKIN REACTION OR SURGICAL SITE INFECTION CANNOT BE RULE OUT. SINCE NO OTHER COMPLICATIONS WERE REPORTED AND PATIENT´S HEALTH CONDITION IS STABLE, NO FURTHER CLINICAL/MEDICAL ASSESSMENT COULD BE RENDERED BASED ON THE INFORMATION PROVIDED. THE COMPLAINT WAS CONFIRMED, AND THE ROOT CAUSE WAS ASSOCIATED WITH MAINTENANCE. FACTORS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT INCLUDE AN APPLICATION OF UNINTENDED INAPPROPRIATE OR EXCESSIVE FORCE TO THE DEVICE, AN IMPACT EVENT INCONSISTENT WITH NORMAL USE, WEAR FROM PROLONGED USE, MISUSE OR ROUGH HANDLING, OR INADEQUATE ROUTINE MAINTENANCE. PLEASE REFER TO THE INSTRUCTIONS FOR USE FOR RECOMMENDATIONS ON PROPER USE OF THE DEVICE AND POTENTIAL TROUBLESHOOTING METHODS TO PREVENT FUTURE REOCCURRENCE OF THE REPORTED EVENT. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME. IF THE PRODUCT ASSOCIATED WITH THIS EVENT IS RETURNED AT A FUTURE DATE, THIS INVESTIGATION WILL BE REOPENED FOR EVALUATION.

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY BY ENTERING THE LENS INTO THE CANNULA INSIDE THE ARTICULATION THE PHYSICIAN NOTICED AT THE SCREEN AS IF THE LENS WAS BROKEN. THE PHYSICIAN REMOVED THE LENS AND A BLACK STAIN OF DIRT ON THE CANNULA WAS OBSERVED. ANOTHER DEVICE WAS USED IN ORDER TO CONCLUDE THE PROCEDURE. NON-SIGNIFICANT DELAY WAS REPORTED. NO OTHER COMPLICATIONS WERE REPORTED AND PATIENT´S HEALTH CONDITION IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1908319 CANN H.F. DGNST 6MM RTBL DBL VLV ACCESSORIES,ARTHROSCOPIC NBH SMITH & NEPHEW, INC. 72200829 50705044 03596010573520

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention