MAUDE Adverse Event Report: ARTHREX, INC. IMPL SYS, ALLOGRAFT GRAFTLINK CP 2; NON-DEGRADABLE FIXATN FASTENER

Model Number	IMPL SYS, ALLOGRAFT GRAFTLINK CP 2
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2025
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 11/25/2025, it was reported by a sales representative via (b)(4) that an ar-1588al-cp2 flip cutter was unable to close after reaming the first tunnel, appears that debris is stuck in the device.Issue discovered during a case, device swapped, and case completed with no patient effect.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint device was not received for evaluation.Based on the information provided, which may include the returned device (if available), pictures, videos, event descriptions, and any additional field data, arthrex concluded the most likely cause of the reported failure.The most likely cause of the reported failure is a user error, including debris stuck in the device.The complaint allegation was not confirmed.No evidence of that failure was received.

• Brand Name: IMPL SYS, ALLOGRAFT GRAFTLINK CP 2
• 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: 23777841
• Report Number: 1220246-2025-05586
• Device Sequence Number: 9933903
• Product Code: MBI
• UDI-Device Identifier: 00888867395350
• UDI-Public: (01)00888867395350(11)250619(17)290331(10)15453793
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K241235
• 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): 03/31/2026

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: IMPL SYS, ALLOGRAFT GRAFTLINK CP 2
• Device Catalogue Number: AR-1588AL-CP2
• Device Lot Number: 15453793
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2025
• Supplement Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 12/11/2025
• Supplement Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/19/2025
• 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