MAUDE Adverse Event Report: Arthrex, Inc. BTB TIGHTROPE W/ DEPLOYING SUTURE; SMOOTH FIXATION PIN

Model Number	BTB TIGHTROPE W/ DEPLOYING SUTURE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 9 sep 2026, it was reported by an arthrex employee via email that an ar-1588btb-j btb tightrope w/ deploying suture's lead suture snapped while attempting to pass it through the tightrope because the suture was too stiff to go through.This occurred during graft preparation for a aclr (btb) procedure.The procedure was completed successfully by using another ar-1588btb-j.There was no patient harm.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: BTB TIGHTROPE W/ DEPLOYING SUTURE
• Common Device Name: SMOOTH FIXATION PIN
• Manufacturer (Section D): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer (Section G): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer Contact: jared engle ; +1(800)933-7001
• MDR Report Key: 50867215
• Report Number: 1220246-2026-04860
• Device Sequence Number: 9425388
• Product Code: MBI
• UDI-Device Identifier: 00888867095366
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 09/23/2026

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: BTB TIGHTROPE W/ DEPLOYING SUTURE
• Device Catalogue Number: AR-1588BTB-J
• Device Lot Number: 15419114
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/10/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown