BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CANN H.F. DGNST 6MM RTBL DBL VLV

    MDR report key: 15843461 · Received November 22, 2022

    Report

    Report Number
    1219602-2022-01790
    Event Type
    Injury
    Date Received
    November 22, 2022
    Date of Event
    November 1, 2022
    Report Date
    December 2, 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
    BR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: (B)(4).

    Additional Manufacturer Narrative · 0

    H2: ADDITIONAL INFORMATION IN B5. H10: THE INFORMATION RECEIVED BY THE MANUFACTURER HAS BEEN RE-EVALUATED FOR MDR REPORTING AND IT WAS DETERMINED THAT THIS CASE DOES NOT MEET THE THRESHOLD FOR REPORTING AND IS A NON-REPORTABLE EVENT. ADDITIONAL INFORMATION RECEIVED CONFIRMED THE BROKEN PART IS THE PART WHERE THE SURGEON PLACES HIS HAND TO HOLD THE INSTRUMENT AND USE IT. THEREFORE, THE BROKEN PART OF THE INSTRUMENT CAN BE REMOVED WITH THE SURGEON'S OWN HAND AND NO MEDICAL/SURGICAL INTERVENTION IS REQUIRED. IF FURTHER DETAILS ARE PROVIDED CONFIRMING THE OCCURRENCE OF A REPORTABLE EVENT, OUR FILES WILL BE UPDATED ACCORDINGLY AND A FURTHER REPORT SUBMITTED OUTLINING BOTH THE EVENT DETAILS AND OUR INVESTIGATIONS PERFORMED. CORRECTED INFORMATION IN B1.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY, WHEN THE SURGEON MADE A LITTLE STRENGTH TO LOOSEN THE DOUBLE VALVE CANNULA, IT BROKE. THE BROKEN PART WAS REMOVED FROM THE PATIENT. THE SURGERY WAS RESUMED, AFTER A NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. THE CURRENT PATIENT'S HEALTH CONDITION IS STABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY, WHEN THE SURGEON MADE A LITTLE STRENGTH TO LOOSEN THE DOUBLE VALVE CANNULA, IT BROKE. HOWEVER, NOTHING WAS LEFT INSIDE THE PATIENT BECAUSE THE BROKEN PART IS WHERE THE SURGEON PLACES HIS HAND TO HOLD THE INSTRUMENT AND USE IT. THE SURGERY WAS RESUMED, AFTER A NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. THE CURRENT PATIENT'S HEALTH CONDITION IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2686285 CANN H.F. DGNST 6MM RTBL DBL VLV ACCESSORIES,ARTHROSCOPIC NBH SMITH & NEPHEW, INC. 72200829 UNKNOWN 03596010573520

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Required Intervention