BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKN NON-ABSORBABLE SUTURE AND TAPE

    MDR report key: 20600689 · Received November 4, 2024

    Report

    Report Number
    1219602-2024-02402
    Event Type
    Injury
    Date Received
    November 4, 2024
    Report Date
    February 6, 2025
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    GAT
    PMA / PMN Number
    K132357
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE (B)(4). ARTICLE: IBÁN, M. A. R., DÍAZ, R. R., DE RUS AZNAR, I., COMINO, C. V., & HEREDIA, J. D. (2023). ANATOMIC ACROMIOCLAVICULAR AND CORACOCLAVICULAR LIGAMENT RECONSTRUCTION WITH ALLOGRAFT IS EFFECTIVE FOR THE MANAGEMENT OF NON-ACUTE ACROMIOCLAVICULAR DISLOCATIONS. INJURY, 54, 111047. H3, H6: THIS COMPLAINT WAS OPENED BY SMITH+NEPHEW TO DOCUMENT A PATIENT COMPLICATION IDENTIFIED THROUGH A REVIEW OF CLINICAL EVIDENCE FROM LITERATURE SOURCES THAT INCLUDES REFERENCE TO THE USE OF A SMITH+NEPHEW PRODUCT. THE REPORTED ISSUE(S) RELATE TO KNOWN INHERENT PROCEDURAL RISKS THAT ARE APPROPRIATELY DOCUMENTED IN OUR RISK FILES. SMITH+NEPHEW WILL CONTINUE TO MONITOR TRENDS IN ACCORDANCE WITH OUR POST-MARKET SURVEILLANCE PROCESS AND TAKE NECESSARY ACTION AS REQUIRED IF ANTICIPATED SEVERITY AND/OR OCCURRENCE RATES ARE EXCEEDED. SMITH+NEPHEW HAS NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY SPECIFICATIONS AT THE TIME OF MANUFACTURE. BASED ON OUR REVIEW OF ALL CURRENTLY AVAILABLE INFORMATION, WE ARE UNABLE TO CONFIRM A RELATIONSHIP BETWEEN THE REPORTED EVENT AND THE DEVICE OR IDENTIFY A DEFINITIVE ROOT CAUSE. HOWEVER, AS THE USE OF OUR PRODUCT CANNOT BE EXCLUDED AS A POTENTIAL CAUSE OR CONTRIBUTORY FACTOR TO THE REPORTED ISSUE, WE ARE CONSERVATIVELY SUBMITTING THIS REPORT IN ACCORDANCE WITH APPLICABLE REGULATIONS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THAT ALTERS THE CONCLUSIONS OF THIS REPORT, A FOLLOW-UP REPORT WILL BE SUBMITTED AS REQUIRED.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: H6 (HEALTH EFFECT - IMPACT CODE). UPDATED RESULTS OF INVESTIGATION: A DEVICE DEFICIENCY WAS NOT IDENTIFIED, AND THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED DUE TO THE LIMITED CLINICAL INFORMATION PROVIDED. INSUFFICIENT PRODUCT IDENTIFICATION INFORMATION WAS PROVIDED AND THUS A MANUFACTURING RECORD REVIEW, COMPLAINT HISTORY REVIEW, RISK MANAGEMENT REVIEW AND INSTRUCTIONS FOR USE 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. A CLINICAL REVIEW STATES THAT THE ROOT CAUSE AND/OR PATIENT OUTCOME BEYOND THAT WHICH WAS DOCUMENTED IN THE ARTICLE CANNOT BE CONFIRMED NOR CONCLUDED. THE IMAGES AND DOCUMENTS/REFERENCED IN THE ARTICLE HAVE BEEN INTERPRETED WITHIN THE TEXT. IT WAS COMMUNICATED VIA E-MAIL THAT THE PATIENTS WERE ASYMPTOMATIC AND DID NOT REQUIRE FURTHER TREATMENT. THE OUTCOME WAS NOTED AS ¿EXCELLENT.¿ BASED ON THE LIMITED INFORMATION PROVIDED A THOROUGH MEDICAL ASSESSMENT COULD NOT BE PERFORMED; THEREFORE, WE ARE UNABLE TO CONCLUDE SPECIFIC FACTORS KNOWN TO CONTRIBUTE TO THE ALLEGED REPORT. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON LITERATURE REVIEW ANATOMIC ACROMIOCLAVICULAR AND CORACOCLAVICULAR LIGAMENT RECONSTRUCTION WITH ALLOGRAFT IS EFFECTIVE FOR THE MANAGEMENT OF NON-ACUTE ACROMIOCLAVICULAR DISLOCATIONS" BETWEEN JANUARY 2015 TO JANUARY 2020, 6 PATIENTS HAD OSTEOLYSIS OF THE DISTAL CLAVICLE AND MILD DEGENERATIVE CHANGES IN THE ACROMIOCLAVICULAR JOINTS AFTER AN ANATOMIC ACROMIOCLAVICULAR AND CORACOCLAVICULAR LIGAMENT RECONSTRUCTION PROCEDURE USING A ULTRATAPE DEVICE. IT IS UNKNOWN HOW WERE THE PATIENTS TREATED. PATIENTS OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788308 UNKN NON-ABSORBABLE SUTURE AND TAPE SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT SMITH & NEPHEW, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other