MAUDE Adverse Event Report: ARTHREX, INC. 2.6 DL KNOTLESS FIBERTAK; NON-DEGRADABLE FIXATN FASTENER

Model Number	2.6 DL KNOTLESS FIBERTAK
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 02-jan-2026, a sales representative reported via phone that during a rotator cuff repair procedure, two ar-3642sp knotless 2.6 fibertak double loaded anchors with #2 kl repair sutures were implanted.Both shuttling loops broke on each anchor after implantation.The anchors remained in situ, and the broken sutures were removed.Two additional ar-3642sp anchors from a different lot were utilized without issue to complete the case.There was no surgical delay, no additional anesthesia administered, and no patient harm reported.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to user error of the device due to excessive force used during suture passing/tightening /tensioning.

• Brand Name: 2.6 DL KNOTLESS FIBERTAK
• Common Device Name: NON-DEGRADABLE FIXATN FASTENER
• 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: 24108248
• Report Number: 1220246-2026-00237
• Device Sequence Number: 9784223
• Product Code: MBI
• UDI-Device Identifier: 00888867426429
• UDI-Public: (01)00888867426429(11)230612(17)280531(10)15103419
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 05/05/2026

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: 2.6 DL KNOTLESS FIBERTAK
• Device Catalogue Number: AR-3642SP
• Device Lot Number: 15103419
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2026
• Supplement Date Received by Manufacturer: 05/04/2026
• Initial Report FDA Received Date: 01/19/2026
• Supplement Report FDA Received Date: 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/12/2023
• 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
• Patient Sex: Unknown