BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKN DOUBLE ENDOBUTTON DEV

    MDR report key: 20023281 · Received August 21, 2024

    Report

    Report Number
    1219602-2024-01771
    Event Type
    Injury
    Date Received
    August 21, 2024
    Report Date
    August 16, 2024
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    MBI
    PMA / PMN Number
    K980155
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE (B)(4). H10: 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON LITERATURE REVIEW SURGICAL ACCIDENTS AND POSTOPERATIVE COMPLICATIONS OF RECURRENT SHOULDER DISLOCATION TREATED BY SUTURE BUTTON FIXATION WITH BONE OCCLUSION, 1 PATIENT HAD A CORACOIDAL PROCESS FRACTURE THAT OCURRED WHEN DRILLING ON THE AXE, THE DRILLED BONE TUNNEL WAS NOT AF THE CENTER OF THE AXE AND THERE WAS OBVIOUS OSTEOPOROSIS, WHICH LED TO THE SPLITTING OF THE AXE BONE BLOCK DURING A SUTURE BUTTON FIXATION WITH BONE OCCLUSION PROCEDURE USING AN ENDOBUTTON DEVICE. AFTER EXPLORATION, IT WAS CONSIDERED TO BE FIXED AND STABLE, AND CONSERVATIVE REHABILITATION TREATMENT WAS GIVEN WITH GOOD EFFECT. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2273372 UNKN DOUBLE ENDOBUTTON DEV FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI SMITH & NEPHEW, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| O