BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKN PEEK SUTURE ANCHOR

    MDR report key: 11750447 · Received April 29, 2021

    Report

    Report Number
    1219602-2021-00990
    Event Type
    Injury
    Date Received
    April 29, 2021
    Date of Event
    January 31, 2021
    Report Date
    June 13, 2021
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    MBI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H3, H6: 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 COMPLAINT HISTORY REVIEW CONCLUDED THIS WAS A REPEAT ISSUE. 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 REVIEW OF RISK MANAGEMENT FILES FOUND THAT THE REPORTED FAILURE WAS DOCUMENTED APPROPRIATELY. ATTEMPTS TO OBTAIN MEDICAL DOCUMENTS WERE UNSUCCESSFUL AND THUS A THOROUGH MEDICAL INVESTIGATION WAS NOT PERFORMED. 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

    (B)(4). LITERATURE: PROSPECTIVE, RANDOMIZED EVALUATION OF LATISSIMUS DORSI TRANSFER AND SUPERIOR CAPSULAR RECONSTRUCTION IN MASSIVE, IRREPARABLE ROTATOR CUFF TEARS. DOI: HTTPS://DOI.ORG/10.1016/J.JSE.2021.01.036.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON LITERATURE REVIEW: "PROSPECTIVE, RANDOMIZED EVALUATION OF LATISSIMUS DORSI TRANSFER AND SUPERIOR CAPSULAR RECONSTRUCTION IN MASSIVE, IRREPARABLE ROTATOR CUFF TEARS", A PATIENT EXPERIENCED SEPTIC ARTHRITIS AFTER LDT SURGERY WITH A FOOTPRINT ULTRA PK. THIS WAS TREATED WITH REVISION SURGERIES AND GRAFT REMOVAL. THE PATIENT HAD A STIFF AND DYSFUNCTIONAL SHOULDER AFTERWARD. NO FURTHER INFORMATION IS AVAILABLE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641813 UNKN PEEK SUTURE ANCHOR FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI SMITH & NEPHEW, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1