BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CANN 5.5 WO/HOLES LTX FREE ORANGE

    MDR report key: 15203179 · Received August 10, 2022

    Report

    Report Number
    1219602-2022-01133
    Event Type
    Injury
    Date Received
    August 10, 2022
    Report Date
    September 19, 2022
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    NBH
    UDI-DI
    03596010250667
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: (B)(4).

    Additional Manufacturer Narrative · 0

    H10: H3, 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. THERE WAS NO RELATIONSHIP FOUND BETWEEN THE DEVICE AND THE REPORTED EVENT. A COMPLAINT HISTORY REVIEW FOUND SIMILAR REPORTED EVENTS. 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 FINDS TWO EMPTY PACKAGES THAT CONFIRM THE DEVICE INFORMATION FOR THIS COMPLAINT AND THE -2 COMPLAINT AS WELL. IT WAS REPORTED THAT DURING A SHOULDER PROCEDURE, THE DISTAL TIP OF TWO (2) CANNULA DEVICES SHREDDED INSIDE THE PATIENT'S SHOULDER. IT IS UNKNOWN HOW THE ISSUE WAS RESOLVED AND IF THERE WAS A SURGICAL DELAY OR IF A BACKUP DEVICE WAS AVAILABLE. NO RELEVANT SUPPORTING CLINICAL INFORMATION HAS BEEN PROVIDED TO ASSIST WITH A CLINICAL INVESTIGATION. THEREFORE, BASED ON INSUFFICIENT INFORMATION, A THOROUGH CLINICAL ASSESSMENT CANNOT BE PERFORMED AT THIS TIME. IT IS UNKNOWN IF BONE QUALITY OR SURGICAL TECHNIQUE COULD HAVE CONTRIBUTED TO THE BREAKAGE. THE PATIENT'S CURRENT CONDITION IS UNKNOWN AND THE PATIENT IMPACT BEYOND THE REPORTED EVENTS COULD NOT BE DETERMINED BASED ON THE LIMITED INFORMATION PROVIDED. SHOULD ANY ADDITIONAL CLINICAL INFORMATION BE PROVIDED, THIS COMPLAINT WILL BE RE-EVALUATED. THE COMPLAINT WAS NOT CONFIRMED. FACTORS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT INCLUDE AN APPLICATION OF UNINTENDED INAPPROPRIATE OR EXCESSIVE FORCE TO THE DEVICE, ATTEMPTED CORRECTION OF A DAMAGED DEVICE, OR AN IMPACT EVENT INCONSISTENT WITH NORMAL USE. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A SHOULDER PROCEDURE, THE DISTAL TIP OF TWO (2) CANNULA DEVICES ((B)(4), LN: 2080429 & (B)(4), LN: 2084981) SHREDDED INSIDE THE PATIENT'S SHOULDER. IT IS UNKNOWN HOW THE ISSUE WAS RESOLVED AND IF THERE WAS A SURGICAL DELAY OR IF A BACKUP DEVICE WAS AVAILABLE. NO FURTHER COMPLICATION WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1523671 CANN 5.5 WO/HOLES LTX FREE ORANGE ACCESSORIES,ARTHROSCOPIC NBH SMITH & NEPHEW, INC. 7204895 2080429 03596010250667

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention