BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN METAL SUTURE ANCHOR

    MDR report key: 15728040 · Received November 4, 2022

    Report

    Report Number
    1219602-2022-01670
    Event Type
    Injury
    Date Received
    November 4, 2022
    Date of Event
    July 9, 2020
    Report Date
    December 29, 2022
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JDR
    PMA / PMN Number
    K972326
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: (B)(4). ARTICLE: SUN, Q., GE, W., LI, G., WU, J. Z., LU, G., LI, R., ... & CAI, M. (2020). PLATE FIXATION VERSUS ARTHROSCOPIC-ASSISTED PLATE FIXATION FOR ISOLATED MEDIUM-SIZED FRACTURES OF THE GREATER TUBEROSITY: A RETROSPECTIVE STUDY. ORTHOPAEDIC SURGERY, 12(5), 1456-1463.

    Additional Manufacturer Narrative · 0

    H10: INTERNAL COMPLAINT REFERENCE (B)(4). 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, COMPLAINT HISTORY REVIEW, RISK MANAGEMENT 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 CLINICAL REVIEW STATES 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. IN ADDITION, THE PHYSICIAN REFERENCED IN THE ABSTRACT PROVIDED AN ANALYSIS OF ALL OF THE ATTACHED IMAGES. THEREFORE, NO FURTHER INTERPRETATION OF THE ATTACHED IMAGES ARE REQUIRED. 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 PLATE FIXATION VERSUS ARTHROSCOPIC-ASSISTED PLATE FIXATION FOR ISOLATED MEDIUM-SIZED FRACTURES OF THE GREATER TUBEROSITY: A RETROSPECTIVE STUDY, 1 PATIENT HAD A FRACTURE MALUNION AFTER AN ARTHROSCOPIC-ASSISTED PLATE FIXATION PROCEDURE USING TWO(2) TWINFIX TI ANCHORS. THE PATIENT REFUSED TO UNDERGO REOPERATION. PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2797777 UNKNOWN METAL SUTURE ANCHOR STAPLE, FIXATION, BONE JDR SMITH & NEPHEW, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other