BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKN MANUAL INSTR

    MDR report key: 15656790 · Received October 23, 2022

    Report

    Report Number
    1219602-2022-01599
    Event Type
    Injury
    Date Received
    October 23, 2022
    Date of Event
    January 1, 2018
    Report Date
    December 15, 2022
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    MBI
    PMA / PMN Number
    K980155
    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).

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE (B)(4). 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. INSUFFICIENT PRODUCT IDENTIFICATION INFORMATION WAS PROVIDED AND THUS A MANUFACTURING RECORD REVIEW COULD NOT BE CONDUCTED. BASED ON THE INFORMATION AVAILABLE, THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATIONS UPON RELEASE FOR DISTRIBUTION. INSUFFICIENT PRODUCT IDENTIFICATION INFORMATION WAS PROVIDED AND THUS A COMPLAINT HISTORY REVIEW COULD NOT BE CONDUCTED. INSUFFICIENT PRODUCT IDENTIFICATION INFORMATION WAS PROVIDED, AND THUS, AN INSTRUCTION FOR USE REVIEW COULD NOT BE CONDUCTED. INSUFFICIENT PRODUCT IDENTIFICATION INFORMATION WAS PROVIDED AND THUS A RISK MANAGEMENT REVIEW COULD NOT BE CONDUCTED. 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. 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. 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, 11 PATIENTS REQUIRED REOPERATION AFTER A SINGLE BUNDLE TECHNIQUE PROCEDURE USING AN ENDOBUTTON CL AND PEEK INTERFERENCE SCREW. 1 PATIENT WAS FOR A REVISION, 1 PATIENT FOR A MENISCAL SUGERY, 3 PATIENTS FOR LAVAGE, 3 PATIENTS DUE TO CYCLOPS/EXTENSION DEFICIT AND 5 OTHER PATIENTS FOR UNKNOWN CAUSES. PATIENTS OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2016961 UNKN MANUAL INSTR FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI SMITH & NEPHEW, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other