MAUDE Adverse Event Report: ARTHREX, INC. FBRTK SPDBRG IMP SYS W/ BC SWVLK; NON-DEGRADABLE FIXATN FASTENER

Model Number	FBRTK SPDBRG IMP SYS W/ BC SWVLK
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2025
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 10/03/2025, it was reported by a sales representative via (b)(4) that an ar-2600fsb-3 fbrtk spdbrg fiber tape suture was frayed.This was discovered during the case with no patient harm.Additional information was received from rep on 10/09/25.This was discovered during a rotator cuff repair on (b)(6) 2025.One kit was used and this occurred during insertion.The case was completed using another device of the same part number.There was no delay in surgery and no additional anesthesia was used.The device is not available for return, and no photos were taken.
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: FBRTK SPDBRG IMP SYS W/ BC SWVLK
• 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: 23389501
• Report Number: 1220246-2025-04819
• Device Sequence Number: 9970090
• Product Code: MBI
• UDI-Device Identifier: 00888867429871
• UDI-Public: (01)00888867429871(11)250203(17)290131(10)15382635
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K222263
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2025

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: FBRTK SPDBRG IMP SYS W/ BC SWVLK
• Device Catalogue Number: AR-2600FSB-3
• Device Lot Number: 15382635
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2025
• Supplement Date Received by Manufacturer: 12/03/2025
• Initial Report FDA Received Date: 10/27/2025
• Supplement Report FDA Received Date: 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/03/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown