MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ENDOBUTTON CL ULTRA 20MM; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	72200147
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fever (1858); Synovitis (2094); Impaired Healing (2378)
Date of Event	07/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, six weeks after a left knee anterior cruciate ligament reconstruction surgery + arthroscopic meniscus shaping surgery + arthroscopic knee synovectomy surgery + tendon excision surgery + joint therapeutic substance injection, which was performed on (b)(6) 2024 and in which a 20 mm endobutton cl ultra was inserted, the patient had poor wound healing.On (b)(6) 2024, under general anesthesia, a debridement and vsd drainage were performed for poor wound healing after the primary surgery of the left anterior cruciate ligament.On (b)(6) 2024, approximately, the patient experienced recurrent fever with a maximum temperature of 38.5 degrees celsius and the blood test results showed 80.5% neutrophils and 141.89mg/l c-reactive protein.The patient was treated with vancomycin 1.0g q12h.On (b)(6) 2024, under general anesthesia, the patient underwent arthroscopic cleaning of the left knee surgery with poor wound healing.During this revision surgery, purulent fluid accumulation and synovial infection were observed in the knee joint, and the anterior cruciate ligament graft failed.Knee joint synovial cleaning was performed, and a drainage tube was placed.The anchor remained secured in the patient.The patient's body temperature and inflammatory indicators decreased significantly after surgery and antibiotic treatment.There was no abnormal exudation at the surgical incision site and no tenderness locally.Regular postoperative blood routine, crp, esr, and descending pressure tests were conducted.Calcinogen, interleukin-6, liver and kidney function with stable condition.The patient was recovered from the infection and was discharged on (b)(6) 2024.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).H3, h6: this complaint was opened by smith+nephew to document a product problem associated with a smith+nephew device.The reported problem relates to known inherent device and/or 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 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 investigative findings or information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.

• Brand Name: ENDOBUTTON CL ULTRA 20MM
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 21134449
• Report Number: 1219602-2025-00092
• Device Sequence Number: 20539268
• Product Code: MBI
• UDI-Device Identifier: 03596010597267
• UDI-Public: 3596010597267
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K980155
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/12/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 72200147
• Device Lot Number: 2101765
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2024
• Initial Report FDA Received Date: 01/12/2025
• Date Device Manufactured: 09/28/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 34 YR
• Patient Sex: Female