MAUDE Adverse Event Report: Arthrex, Inc. DX FiberTak Suture Anchor, #1 FW & NDLs; NON-DEGRADABLE FIXATN FASTENER

Model Number	DX FiberTak Suture Anchor, #1 FW & NDLs
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2026, an arthrex employee reported on behalf of an individual who underwent bilateral peroneus brevis and peroneus longus repair procedure and had an arthrex fibertak anchor implanted.The employee stated that, during a meeting with the patient on (b)(6) 2026, the patient reported that the implant did not help and that they were experiencing daily pain.No further information was provided.Additional information was received on 21-sep-2026: the reporter stated that the individual indicated the reported pain may be unrelated to the treatment and could be associated with rheumatoid arthritis.Review of the operative report dated (b)(6) 2023 indicates that the following arthrex implants were implanted on the right side: two kt internalbrace biocomposite 4.75 mm implants and two ar-8990 fibertak dx suture anchors.No infection was documented at the time of surgery.No intraoperative complications were reported.The patient was transferred to pacu in stable condition and subsequently discharged home.Review of the operative report dated (b)(6) 2023 indicates that the following arthrex implants were implanted on the left side: one ar-1789j-cp internalbrace implant system and three ar-8990 fibertak dx suture anchors.No infection was documented at the time of surgery.No intraoperative complications were reported.The patient was transferred to pacu in stable condition and subsequently discharged home.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: DX FiberTak Suture Anchor, #1 FW & NDLs
• Common Device Name: NON-DEGRADABLE FIXATN FASTENER
• 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: 50886176
• Report Number: 1220246-2026-04882
• Device Sequence Number: 15909172
• Product Code: MBI
• UDI-Device Identifier: 00888867265004
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K172612
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

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: DX FiberTak Suture Anchor, #1 FW & NDLs
• Device Catalogue Number: AR-8990
• Device Lot Number: 15071149
• 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: 08/27/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/22/2023
• 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