BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AWL TAPERED 3.8MM

    MDR report key: 15578504 · Received October 11, 2022

    Report

    Report Number
    1219602-2022-01502
    Event Type
    Injury
    Date Received
    October 11, 2022
    Date of Event
    September 21, 2022
    Report Date
    April 18, 2023
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    NBH
    UDI-DI
    03596010610607
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 0

    H3, H6: THE REPORTED DEVICE WAS RECEIVED FOR EVALUATION. THERE WAS A 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 AND/OR HARM WAS DOCUMENTED APPROPRIATELY, AND THERE WERE NO INDICATIONS TO SUGGEST THE ANTICIPATED RISK IS NOT ADEQUATE. A VISUAL INSPECTION OF THE RETURNED DEVICE FOUND THAT IT IS NOT IN ITS ORIGINAL PACKAGING. THE DISTAL TIP OF THE SHAFT IS FRACTURED AWAY. THE SHAFT AND HANDLE WERE RETURNED WITHOUT THE TIP THAT FRACTURED AWAY. OF THE TWO PROVIDED UNDATED/UNLABELED PHOTOS (BOTH REVIEWED) ONE PHOTO APPEARS TO SHOW THE DEVICE WITH A BROKEN TIP AND THE OTHER PHOTOS APPEARS TO SHOW AN INTACT DEVICE. THE PATIENT IMPACT BEYOND THE REPORTED IS NOT ANTICIPATED AS ¿ALL PIECES¿ WERE REPORTEDLY RETRIEVED. PER CASE DETAILS, IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED, HOWEVER THE PROCEDURAL DELAY WAS ¿NON-SIGNIFICANT WITHOUT ANY PATIENT INJURY BEING ALLEGED. THEREFORE, NO FURTHER CLINICAL/MEDICAL ASSESSMENT IS WARRANTED THE COMPLAINT WAS CONFIRMED, AND THE ROOT CAUSE WAS ASSOCIATED WITH UNINTENDED USE OF THE DEVICE. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE, THE DISTAL TIP OF THE AWL TAPERED SHAFT BROKE WHEN IT WAS HAMMERED INTO THE HUMERAL HEAD. ALL THE PIECES WERE RETRIEVED FROM THE PATIENT. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED; HOWEVER, A NON-SIGNIFICANT DELAY WAS REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2703554 AWL TAPERED 3.8MM ACCESSORIES,ARTHROSCOPIC NBH SMITH & NEPHEW, INC. 72201915 50997522 03596010610607

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention