MAUDE Adverse Event Report: ARTHREX, INC. SP FBRTAK RC FBRTPE BLK/BLU & STTPE BLU; NON-DEGRADABLE FIXATN FASTENER

Model Number	SP FBRTAK RC FBRTPE BLK/BLU & STTPE BLU
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/15/2025
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 21-jan-2026, it was reported by a sales representative via email that an ar-3652ttsp fibertak rc was used during a procedure, and the suture tape was snapping.This issue was discovered intraoperatively.Additional information was received on 02-feb-2026: on (b)(6) 2025, during a rotator cuff repair procedure, the suture tape snapped intraoperatively while inside the patient.The suture tape and all associated fragments were removed.The case was completed using a replacement ar-3652ttsp fibertak rc suture anchor.The procedure experienced an approximate 10-minute delay, and no additional anesthesia was required.

• Brand Name: SP FBRTAK RC FBRTPE BLK/BLU & STTPE BLU
• 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: 24306319
• Report Number: 1220246-2026-00506
• Device Sequence Number: 9652237
• Product Code: MBI
• UDI-Device Identifier: 00888867362949
• UDI-Public: (01)00888867362949(11)251110(17)301031(10)15528409
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 05/19/2026

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 FBRTAK RC FBRTPE BLK/BLU & STTPE BLU
• Device Catalogue Number: AR-3652TTSP
• Device Lot Number: 15528409
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2026
• Supplement Date Received by Manufacturer: 05/14/2026
• Initial Report FDA Received Date: 02/10/2026
• Supplement Report FDA Received Date: 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2025
• 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