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	Foreign Body In Patient (2687)
Date of Event	10/10/2025
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 10/10/2025, a sales representative reported via phone that an ar-2600fsb-1 fibertak® speedbridge¿ implant systems sutures began to fray.This occurred during a rotator cuff repair on (b)(6) 2025 when the suture on the fibertak anchor was passed through the rotator cuff.The surgeon began to tension and when the tension was placed on the sutures, they began to fray.The device was still used in this procedure, and the anchor was secured.There was no major delay during this event, and no harm to the patient.Additional information was provided on 10/10/2025 where it was reported that an ar-3650ds was used to prepare the bone socket for insertion of the implant.The surgeon used the drill guide to get his location on the articular margin and drilled with the 2.6 drill bit.The patient had good bone quality and all three 2.6 fibertak anchors were inserted correctly and set well against the cortical bone.It appeared that suture fragments entered the patient.However, the surgeon used a shaver and grasper to retrieve, and it appears that the frayed sutures were removed.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on visual inspection and analysis of 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: 23404111
• Report Number: 1220246-2025-04849
• Device Sequence Number: 4928190
• Product Code: MBI
• UDI-Device Identifier: 00888867429857
• UDI-Public: (01)00888867429857(11)250602(17)290531(10)15445045
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K222263
• 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): 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-1
• Device Lot Number: 15445045
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2025
• Supplement Date Received by Manufacturer: 12/03/2025
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/02/2025
• 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