BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKN SUSPENSORY FIXATION DEV

    MDR report key: 12465495 · Received September 13, 2021

    Report

    Report Number
    1219602-2021-01955
    Event Type
    Injury
    Date Received
    September 13, 2021
    Date of Event
    May 24, 2018
    Report Date
    October 3, 2022
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    GAT
    PMA / PMN Number
    K980155
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10: 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. THE DATA PRESENTED IN THIS ARTICLE REPORTS THAT A REVISION SURGERY WAS PERFORMED. HOWEVER, PER CASE DETAILS, NO FURTHER INFORMATION IS AVAILABLE. WITHOUT CLINICALLY RELEVANT PATIENT-SPECIFIC SUPPORTING DOCUMENTATION, A THOROUGH MEDICAL INVESTIGATION COULD NOT BE PERFORMED. THE ROOT CAUSE AND/OR PATIENT OUTCOME BEYOND THAT WHICH WAS DOCUMENTED IN THE ARTICLE COULD NOT 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.¿ ¿

    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, THE ENDOBUTTON SLIPPED OUT. A REVISION SURGERY WAS REQUIRED, AND A CHANGE TO A KOOKED PLATE. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1362340 UNKN SUSPENSORY FIXATION DEV SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT SMITH & NEPHEW, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention