MAUDE Adverse Event Report: Arthrex, Inc. SuturePatch Trapezoid, 45 x 35mm; Mesh, surgical, polymeric

Model Number	SuturePatch Trapezoid, 45 x 35mm
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Foreign Body Reaction (1868)
Date of Event	07/31/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On 16 september 2026, it was reported by a sales representative via email that an ar-7292, suturepatch trapezoid 45 x 35mm was reported to have the case done on (b)(6).Large rotator cuff repair, fibertak 2.6mm medial, into 3.5mm pushlock laterally.The cuff was augmented with a suture patch graft and fixated with fiber stitch 1.5mm in an all-arthroscopic repair.The patient presented with an inflammatory response 3 months post op and was reoperated on (b)(6) 2026 to debride and clean out.Biopsy was taken and the report showed an immune reaction not and infection.This occurred on (b)(6) 2026 during a rotator cuff repair procedure.The case was completed successfully.There was case involvement.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: SuturePatch Trapezoid, 45 x 35mm
• Common Device Name: Mesh, surgical, polymeric
• Manufacturer (Section D): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer (Section G): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer Contact: jared engle ; +1(800)933-7001
• MDR Report Key: 50818142
• Report Number: 1220246-2026-04804
• Device Sequence Number: 18681518
• Product Code: FTL
• UDI-Device Identifier: 00888867301962
• UDI-Public: (01)00888867301962(11)250808(17)300731(10)15480265
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K243480
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 09/18/2026

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 Model Number: SuturePatch Trapezoid, 45 x 35mm
• Device Catalogue Number: AR-7292
• Device Lot Number: 15480265
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2026
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/08/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown