MAUDE Adverse Event Report: ARTHREX, INC. IMPL DELIVERY SYS,ACL T-ROPE RT; NON-DEGRADABLE FIXATN FASTENER

Model Number	IMPL DELIVERY SYS,ACL T-ROPE RT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 11/19/2025, it was reported by an arthrex subsidiary employee via (b)(4) that an ar-1588rts acl tightrope® rt implant delivery system had an implant suture that was damaged and broke when the graft was lifted.This was discovered during use with no patient harm.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint allegation is confirmed based on photographic evidence of an ar-1588rts batch 15458335 with a damaged suture.Based on the information provided ¿ which may include the returned device (if available), photographs, videos, event description, and any additional field input ¿ arthrex has determined the most likely cause.The most likely cause is attributed to user-related factors, such as an insufficiently prepared graft or excessive force used.

• Brand Name: IMPL DELIVERY SYS,ACL T-ROPE RT
• 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: 23744061
• Report Number: 1220246-2025-05479
• Device Sequence Number: 15556807
• Product Code: MBI
• UDI-Device Identifier: 00888867019607
• UDI-Public: (01)00888867019607(11)250630(17)300531(10)15458335
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K241235
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2026

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 DELIVERY SYS,ACL T-ROPE RT
• Device Catalogue Number: AR-1588RTS
• Device Lot Number: 15458335
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2025
• Supplement Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/30/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown