MAUDE Adverse Event Report: ARTHREX, INC. SP FIBERTAK RC, DBLOAD TAPE BL/W, BLK/W; NON-DEGRADABLE FIXATN FASTENER

Model Number	SP FIBERTAK RC, DBLOAD TAPE BL/W, BLK/W
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 13-feb-2026, an arthrex subsidiary employee reported via email that an ar-3632sp 2.6 fibertak sp soft anchor with two 1.3 mm suturetapes experienced breakage at the tip of the shaft after insertion into the bone.The broken piece was retrieved without complication.The anchor otherwise functioned properly and was used to complete the procedure.There was no significant surgical delay, no additional anesthesia was required, and no patient harm was reported.The event occurred during a procedure performed on (b)(6) 2026.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: SP FIBERTAK RC, DBLOAD TAPE BL/W, BLK/W
• 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: 24531548
• Report Number: 1220246-2026-01281
• Device Sequence Number: 18729743
• Product Code: MBI
• UDI-Device Identifier: 00888867341883
• UDI-Public: (01)00888867341883(11)250520(17)300430(10)15439103
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K251809
• 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,Followup
• Report Date (Section B): 06/10/2026

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 FIBERTAK RC, DBLOAD TAPE BL/W, BLK/W
• Device Catalogue Number: AR-3632SP
• Device Lot Number: 15439103
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 02/13/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2026
• Supplement Date Received by Manufacturer: 06/09/2026
• Initial Report FDA Received Date: 03/06/2026
• Supplement Report FDA Received Date: 06/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown