BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKN SUSPENSORY FIXATION DEV

    MDR report key: 12465472 · Received September 13, 2021

    Report

    Report Number
    1219602-2021-01954
    Event Type
    Injury
    Date Received
    September 13, 2021
    Date of Event
    May 24, 2018
    Report Date
    October 15, 2021
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    GAT
    PMA / PMN Number
    K980155
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H10: INTERNAL COMPLAINT REFERENCE: (B)(4). 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. INSUFFICIENT PRODUCT IDENTIFICATION INFORMATION WAS PROVIDED, AND THUS, A MANUFACTURING RECORD REVIEW COULD NOT BE CONDUCTED. 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. WITHOUT CLINICALLY RELEVANT PATIENT-SPECIFIC SUPPORTING DOCUMENTATION, A THOROUGH MEDICAL INVESTIGATION COULD NOT BE PERFORMED. THEREFORE, NO FURTHER MEDICAL ASSESSMENT IS WARRANTED AT THIS TIME. 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

    INTERNAL COMPLAINT REFERENCE (B)(4). XU J, LIU H, LU W, LI D, ZHU W, OUYANG K, WU B, PENG L, WANG D. A RETROSPECTIVE COMPARATIVE STUDY OF ARTHROSCOPIC FIXATION IN ACUTE ROCKWOOD TYPE IV ACROMIOCLAVICULAR JOINT DISLOCATION: SINGLE VERSUS DOUBLE PAIRED ENDOBUTTON TECHNIQUE. BMC MUSCULOSKELET DISORD. 2018 MAY 24;19(1):170. DOI: 10.1186/S12891-018-2104-9. PMID: 29793464; PMCID: PMC5968503.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON LITERATURE REVIEW ¿A RETROSPECTIVE COMPARATIVE STUDY OF ARTHROSCOPIC FIXATION IN ACUTE ROCKWOOD TYPE IV ACROMIOCLAVICULAR JOINT DISLOCATION: SINGLE VERSUS DOUBLE PAIRED ENDOBUTTON TECHNIQUE¿; AFTER THE PROCEDURE USING ENDOBUTTON, TWO PATIENTS HAD DISLOCATION REQUIRING REVISION SURGERY. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1362120 UNKN SUSPENSORY FIXATION DEV SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT SMITH & NEPHEW, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention