BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DOUBLE ENDOBUTTON DEV

    MDR report key: 15626657 · Received October 18, 2022

    Report

    Report Number
    1219602-2022-01558
    Event Type
    Injury
    Date Received
    October 18, 2022
    Date of Event
    January 1, 2018
    Report Date
    December 14, 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

    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. THE IMAGES PROVIDED IN THE ARTICLE HAVE BEEN INTERPRETED WITHIN THE TEXT; THEREFORE, NO FURTHER ANALYSIS OF THE IMAGES IS REQUIRED. IT HAS BEEN COMMUNICATED THAT NO FURTHER INFORMATION IS AVAILABLE INCLUDING THE TREATMENTS TO RESOLVE THE REPORTED EVENTS AND PATIENT OUTCOME. AS OF THE DATE OF THIS MEDICAL INVESTIGATION, THE REQUESTED CLINICAL DOCUMENTATION HAS NOT PROVIDED; THEREFORE, THERE WERE NO CLINICAL FACTORS FOUND WHICH WOULD HAVE DEFINITIVELY CONTRIBUTED TO THE EVENT. THE PATIENTS IMPACT BEYOND THE REPORTED DONOR SITE PAIN AND POSTOPERATIVE PAIN CANNOT BE DETERMINED. THEREFORE, NO FURTHER CLINICAL/MEDICAL ASSESSMENT CAN BE RENDERED. SHOULD ANY ADDITIONAL CLINICAL INFORMATION BE PROVIDED, THIS COMPLAINT MAY BE RE-EVALUATED. 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. 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 DONOR SITE PAIN AND 52 OTHER PATIENTS HAD POSTOPERATIVE PAIN AT A 2 YEAR FOLLOW UP AFTER A SINGLE BUNDLE TECHNIQUE PROCEDURE USING AN ENDOBUTTON CL. 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
    340717 UNKNOWN DOUBLE ENDOBUTTON DEV FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI SMITH & NEPHEW, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other