BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN MANUAL INSTR

    MDR report key: 15618604 · Received October 17, 2022

    Report

    Report Number
    1219602-2022-01549
    Event Type
    Injury
    Date Received
    October 17, 2022
    Date of Event
    January 1, 2018
    Report Date
    December 16, 2022
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    NBH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: (B)(4). ARTICLE: AGA, C., RISBERG, M. A., FAGERLAND, M. W., JOHANSEN, S., TRØAN, I., HEIR, S., & ENGEBRETSEN, L. (2018). NO DIFFERENCE IN THE KOOS QUALITY OF LIFE SUBSCORE BETWEEN ANATOMIC DOUBLE-BUNDLE AND ANATOMIC SINGLE-BUNDLE ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION OF THE KNEE: A PROSPECTIVE RANDOMIZED CONTROLLED TRIAL WITH 2 YEARS¿ FOLLOW-UP. THE AMERICAN JOURNAL OF SPORTS MEDICINE, 46(10), 2341-2354.

    Additional Manufacturer Narrative · 0

    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. THE COMPLAINT WAS NOT CONFIRMED. 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. A CLINICAL REVIEW STATES THE DATA PRESENTED IN THE AGED ARTICLE DOES NOT PROVIDE INSIGHT OR RELEVANCE TO CURRENT CLINICAL OUTCOMES FOR THE PRODUCT/DEVICE. 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 REVIEW, COMPLAINT HISTORY REVIEW, AND AN INSTRUCTIONS FOR USE/DEVICE LABELING REVIEW COULD NOT BE CONDUCTED. BASED ON THE INFORMATION AVAILABLE, THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATION UPON RELEASE FOR DISTRIBUTION. 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. 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 ON LITERATURE REVIEW NO DIFFERENCE IN THE KOOS QUALITY OF LIFE SUBSCORE BETWEEN ANATOMIC DOUBLE-BUNDLE AND ANATOMIC SINGLE-BUNDLE ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION OF THE KNEE, 2 PATIENTS HAD AN INFECTION AFTER A DOUBLE BUNDLE TECHNIQUE PROCEDURE USING A DOUBLE BUNDLE FEMORAL DRILL GUIDE. IT IS UNKNOWN HOW WERE THE EVENTS TREATED. PATIENTS OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2943496 UNKNOWN MANUAL INSTR ACCESSORIES,ARTHROSCOPIC NBH SMITH & NEPHEW, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other