BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ULTRABUTTON DEVICE

    MDR report key: 17514780 · Received August 11, 2023

    Report

    Report Number
    1219602-2023-01463
    Event Type
    Injury
    Date Received
    August 11, 2023
    Date of Event
    March 15, 2022
    Report Date
    October 5, 2023
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    MBI
    PMA / PMN Number
    K153186
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H11: CORRECTED INFORMATION IN D3 (MANUFACTURER NAME, CITY AND ADDRESS). THIS REPORT WAS INADVERTENTLY SUBMITTED UNDER MANUFACTURER NUMBER "1219602", THE CORRECT MANUFACTURER NUMBER IS "3006524618".

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: H6: HEALTH EFFECT - CLINICAL CODE.

    Additional Manufacturer Narrative · 0

    H10: INTERNAL COMPLAINT REFERENCE (B)(4). ARTICLE: VOLZ, R., & BORCHERT, G. H. (2023). RE-RUPTURE RATE AND THE POST-SURGICAL MENISCAL INJURY AFTER ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH THE PRESS-FIT-HYBRID®-TECHNIQUE IN COMPARISON TO THE INTERFERENCE SCREW TECHNIQUE: A RETROSPECTIVE ANALYSIS OF 200 PATIENTS WITH AT LEAST 3 YEARS FOLLOW-UP. ARCHIVES OF ORTHOPAEDIC AND TRAUMA SURGERY, 143(2), 935-949. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT IN LITERATURE REVIEW "RE-RUPTURE RATE AND THE POST-SURGICAL MENISCAL INJURY AFTER ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH THE PRESS-FIT-HYBRID®-TECHNIQUE IN COMPARISON TO THE INTERFERENCE SCREW TECHNIQUE: A RETROSPECTIVE ANALYSIS OF 200 PATIENTS WITH AT LEAST 3 YEARS FOLLOW-UP"; 1 PATIENT HAD FEVER AFTER AN ACL RECONSTRUCTION WITH THE PRESS-FIT-HYBRID®-TECHNIQUE PROCEDURE USING AN ULTRA-BUTTON DEVICE. THE FEVER WAS TREATED WITH AN ARTHROSCOPIC IRRIGATION. THE PATIENT'S OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2181795 UNKNOWN ULTRABUTTON DEVICE FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI ARTHROCARE CORPORATION UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| O