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

Model Number	SP FBRTAK RC FBRTPE BLU & STTPE WH/BLK
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/17/2025
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 17th nov 2025, it was reported by an arthrex's employee via an email that for 1 unit of ar-3652tsp, fibertak® rc suture anchor, (blue), and 1 unit of ar-3653sp, knotless 2.6 fibertak® rc soft anchor, 1.7 mm tigertape¿ loop(white/black), #2 tensionable suture (blue), self-punching, qty.5, the ar-3652tsp was misaligned during use.Ar-3653sp was changed to and the surgeon used the drill and sleeve, but the anchor was still pulled out.This was detected during an instability procedure on (b)(6) 2025.The procedure was completed successfully by opening another type of anchor.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint device was not received for evaluation.Based on the information provided, which may include the device (if available and returned), pictures, videos, event descriptions, and any additional field information, arthrex determined the most likely cause.The most likely cause of the reported and observed failure is user error.This included improper bone preparation, excessive force, misaligned insertion, and/or prying or levering the device during insertion, resulting in device damage.The complaint allegation was confirmed upon reviewing the customer's attached picture, which displayed two devices; it was noted that the inserter of the ar-3652tsp fibertak® rc suture anchor (blue) was bent at the distal end close to the tip.

• Brand Name: SP FBRTAK RC FBRTPE BLU & STTPE WH/BLK
• 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: 23719730
• Report Number: 1220246-2025-05431
• Device Sequence Number: 13286960
• Product Code: MBI
• UDI-Device Identifier: 00888867362925
• UDI-Public: (01)00888867362925(11)250421(17)300331(10)15422903
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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): 03/12/2026

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 BLU & STTPE WH/BLK
• Device Catalogue Number: AR-3652TSP
• Device Lot Number: 15422903
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2025
• Supplement Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/21/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown