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	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2024
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 08/20/2024, a sales representative reported via phone that an ar-2600fsb-1 fibertak speedbridge implant system, while using the ar-3650ds disposables kit for 2.6 fibertak, had an issue with two out of the three 2.6 fibertak rc self-punching soft anchors ripping and pulling out and never fully setting upon implanting.The case was completed using a 4.75 swivelock.There was under 15 minutes of delay in removing the two suture anchors that had ripped.This was discovered during a rotator cuff repair procedure on (b)(6) 2024, with no reported patient harm.
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 due to misaligned insertion and/or improper bone preparation.

• 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: 20180566
• Report Number: 1220246-2024-07481
• Device Sequence Number: 8261898
• Product Code: MBI
• UDI-Device Identifier: 00888867429857
• UDI-Public: 00888867429857
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 06/27/2025

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: 15233838
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2024
• Supplement Date Received by Manufacturer: 06/09/2025
• Initial Report FDA Received Date: 09/10/2024
• Supplement Report FDA Received Date: 06/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/12/2024
• 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