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

Model Number	TKL FBRTK SPDBRG IMP SYS W/ BC SWVLK
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 3/5/2025, it was reported by a sales representative via email that the eyelet of a self-punching swivelock from an ar-2600fsb-2 knotless fibertak speedbridge implant system broke during insertion.Another anchor was opened to complete the case.This was discovered during a procedure on (b)(6) 2025.The patient was not affected.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
Additional information received on 3/18/2025: this was discovered during an rcr procedure.All the broken fragments were retrieved.The case was completed using another ar-2600fsb-2 knotless fibertak speedbridge implant system and an ar-2324kbcsp 4.75 mm biocomposite knotless swivelock.The case was delayed two to three minutes without additional anesthesia.
Additional Manufacturer Narrative
Additional information: b5, h3, h6.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Complaint allegation is confirmed per the picture attached, which shows that the eyelet was broken/bent from the distal end of the shaft.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 method of bone preparation and the quality of the bone encountered were not specified.The most likely cause for the reported failure can be attributed to user error of the device due to improper bone preparation, misalignment insertion, and/or prying/leveraging of the device during insertion.

• Brand Name: TKL 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: 21652594
• Report Number: 1220246-2025-01058
• Device Sequence Number: 20689042
• Product Code: MBI
• UDI-Device Identifier: 00888867429864
• UDI-Public: (01)00888867429864(11)241014(17)280930(10)15331289
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 09/10/2025

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: TKL FBRTK SPDBRG IMP SYS W/ BC SWVLK
• Device Catalogue Number: AR-2600FSB-2
• Device Lot Number: 15331289
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2025
• Supplement Date Received by Manufacturer: Not provided; 09/03/2025
• Initial Report FDA Received Date: 03/20/2025
• Supplement Report FDA Received Date: 04/07/2025; 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/14/2024
• 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