BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKN SMITH+NEPHEW DEV

    MDR report key: 12005370 · Received June 15, 2021

    Report

    Report Number
    3003604053-2021-00223
    Event Type
    Injury
    Date Received
    June 15, 2021
    Date of Event
    September 1, 1999
    Report Date
    July 15, 2021
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    LDQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: (B)(4). THE REPORTED DEVICE, USED IN TREATMENT, WAS NOT RETURNED TO THE DESIGNATED COMPLAINT UNIT FOR INDEPENDENT EVALUATION, THUS VISUAL INSPECTION AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. A CLINICAL EVALUATION DETERMINED THAT NO CLINICALLY RELEVANT INFORMATION WAS PROVIDED. WITHOUT CLINICALLY RELEVANT PATIENT-SPECIFIC SUPPORTING DOCUMENTATION, A THOROUGH MEDICAL INVESTIGATION CANNOT BE PERFORMED. THE ROOT CAUSE AND/OR PATIENT OUTCOME BEYOND THAT WHICH WAS DOCUMENTED IN THE ARTICLE CANNOT BE CONFIRMED NOR CONCLUDED; THEREFORE, NO FURTHER MEDICAL ASSESSMENT IS WARRANTED AT THIS TIME. INSUFFICIENT PRODUCT IDENTIFICATION INFORMATION WAS PROVIDED AND THUS A MANUFACTURING RECORD, COMPLAINT HISTORY, INSTRUCTIONS FOR USE, AND RISK MANAGEMENT REVIEW COULD NOT BE CONDUCTED. A RELATIONSHIP, IF ANY, BETWEEN THE SUBJECT DEVICE AND THE REPORTED EVENT COULD NOT BE DETERMINED. 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 · 1

    INTERNAL COMPLAINT REFERENCE (B)(4). LITERATURE: COMPARISON OF ENDOSCOPIC AND TWO-INCISION TECHNIQUES FOR RECONSTRUCTING A TORN ANTERIOR CRUCIATE LIGAMENT USING HAMSTRING TENDONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON LITERATURE REVIEW ¿COMPARISON OF ENDOSCOPIC AND TWO-INCISION TECHNIQUES FOR RECONSTRUCTING A TORN ANTERIOR CRUCIATE LIGAMENT USING HAMSTRING TENDONS¿, ONE PATIENT HAD LIMITED FLEXION UNDER 100 DEGREES AFTER SURGERY WITH AN S&N ORTHOPEDIC STAPLE. THE COMPLICATION WAS TREATED WITH REVISION SURGERY TO IMPROVE MOTILITY, NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    895842 UNKN SMITH+NEPHEW DEV DEVICE, GENERAL MEDICAL LDQ SMITH & NEPHEW, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other