MAUDE Adverse Event Report: ARTHREX, INC. SP 2.6 MM KNOTLESS FIBERTAK ANCHOR; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	SP 2.6 MM KNOTLESS FIBERTAK ANCHOR
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 10/27/2025 a sales representative reported via phone that (2) ar-3641sp self-punching knotless 2.6 fibertak® anchor with #5sutures failed, the sutures on both frayed.This occurred during a rotator cuff repair on (b)(6) 2025.The first device, the stitch frayed during insertion, was cut out, and the anchor remained in the patient.The second device was used, and the same issue occurred: the stitch frayed during insertion.This second anchor also remained in the patient, and the stitch was cut out.In addition, a third ar-3641sp was used in the procedure.During this procedure, only one of these three devices was intended to be used.The patient had a good bone quality that was prepped using a drill.There was a delay of 10 minutes during which additional anesthesia was administered.There was no harm to the patient.
Additional Manufacturer Narrative
Based on the information provided ¿ which may include the returned device (if available), photographs, videos, event description, and any additional field input ¿ arthrex has determined the most likely cause.The most likely cause is attributed to user-related factors such as off-axis insertion, prying, and leveraging the device during insertion.

• Brand Name: SP 2.6 MM KNOTLESS FIBERTAK ANCHOR
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• 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: 23429196
• Report Number: 1220246-2025-04912
• Device Sequence Number: 9863189
• Product Code: MBI
• UDI-Device Identifier: 00888867341906
• UDI-Public: (01)00888867341906(11)250724(17)300630(10)15471909
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K251809
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SP 2.6 MM KNOTLESS FIBERTAK ANCHOR
• Device Catalogue Number: AR-3641SP
• Device Lot Number: 15471909
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2025
• Supplement Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 10/30/2025
• Supplement Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/24/2025
• 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
• Patient Sex: Unknown