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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2025
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 29th may 2025, it was reported by an arthrex employee via email that for an ar-3652ttsp-1, fibertak® rc suture anchor, (black/blue), the insertor shaft broke upon insertion - shaft tip was retrieved.This was detected during use in an open rotator cuff repair procedure on (b)(6) 2025.The procedure was completed successfully another anchor of the same code was opened.
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 improper bone preparation, misaligned insertion, or prying/leveraging the device with excessive force during use.Per dfu-0054-eo revision 7: " 7.Avoid excessive impaction during anchor insertion as this could lead to inserter damage and/or breakage.If insertion resistance is encountered, do not impact harder.Replace the implant and repeat the drilling/insertion process.8.Visually inspect all devices immediately after use for the potential of loose body remnants left behind in the patient.".

• 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: 22289933
• Report Number: 1220246-2025-02570
• Device Sequence Number: 12876371
• Product Code: MBI
• UDI-Device Identifier: 00888867362956
• UDI-Public: (01)00888867362956(11)241029(17)290930(10)15339511
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K232973
• 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): 09/25/2025

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-1
• Device Lot Number: 15339511
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 05/28/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2025
• Supplement Date Received by Manufacturer: 09/19/2025
• Initial Report FDA Received Date: 06/19/2025
• Supplement Report FDA Received Date: 09/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/29/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown