MAUDE Adverse Event Report: ARTHREX, INC. 3.0 SINGLE LOADED SUTURETAPE S-TAK ASSY; BIO SOFT TISSUE FIXATN FASTNR

Model Number	3.0 SINGLE LOADED SUTURETAPE S-TAK ASSY
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Foreign Body In Patient (2687); Swelling/ Edema (4577)
Date of Event	01/19/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On (b)(6) 2026, the patient reported via phone that they underwent a left ankle arthroscopy with brostrom repair and internal brace on (b)(6) 2025.Approximately five weeks postoperatively, they began experiencing a sensation of something ¿poking through the skin,¿ irritation, decreased range of motion, and sharp pain during weight-bearing.The patient stated they initiated physical therapy on (b)(6) 2025 and have since experienced a progressive decline in range of motion.They rated their current pain as 8¿10 out of 10.The patient reported that recent mri findings showed mild bone swelling around the anchor, and avascular necrosis was suspected, although it is not yet visible on the mri.The (b)(6) 2025 procedure was performed to address chronic left ankle instability following a severe sprain that had not healed adequately.The patient also reported being instructed not to use assistive devices such as crutches or a brace during recovery.At the time of the report, no revision surgery is planned.The arthrex implants implanted in the left ankle arthroscopy with brostrom repair and internal brace on (b)(6) 2025 include ar-1788j-cp internalbrace implant system, ligament augmentation repair, biocomposite, with jumpstart dressing and two ar-8934bcst 3.0 single loaded suturetape s-tak assy.

• Brand Name: 3.0 SINGLE LOADED SUTURETAPE S-TAK ASSY
• Common Device Name: BIO SOFT TISSUE FIXATN FASTNR
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 24605341
• Report Number: 1220246-2026-01417
• Device Sequence Number: 16045285
• Product Code: HWC
• UDI-Device Identifier: 00888867375116
• UDI-Public: (01)00888867375116(11)250407(17)290331(10)15416236
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K082810
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2026

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: 3.0 SINGLE LOADED SUTURETAPE S-TAK ASSY
• Device Catalogue Number: AR-8934BCST
• Device Lot Number: 15416236
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2026
• Supplement Date Received by Manufacturer: 06/30/2026
• Initial Report FDA Received Date: 03/16/2026
• Supplement Report FDA Received Date: 07/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/07/2025
• 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
• Patient Sex: Unknown