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	08/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by an arthrex subsidiary employee via email that an ar-1588btb-j btb tightrope passing suture broke.There was strong resistance when passing on the chinese finger trap, and the passing suture broke.The case was completed using another ar-1588btb-j btb tightrope.This was discovered during a procedure on (b)(6) 2024.Additional information received on (b)(6)2024: this was discovered during an aclr procedure.The suture broke during insertion, and all fragments were removed.The case was not delayed, and no additional anesthesia was needed.
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 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 of the device due to excessive force used during suture passing/tightening /tensioning.

• Brand Name: BTB TIGHTROPE W/ DEPLOYING SUTURE
• Common Device Name: SMOOTH FIXATION PIN
• 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: 20213182
• Report Number: 1220246-2024-07603
• Device Sequence Number: 15326945
• Product Code: MBI
• UDI-Device Identifier: 00888867095366
• UDI-Public: 00888867095366
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K231857
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2025

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: BTB TIGHTROPE W/ DEPLOYING SUTURE
• Device Catalogue Number: AR-1588BTB-J
• Device Lot Number: 15103779
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2024
• Supplement Date Received by Manufacturer: 06/10/2025
• Initial Report FDA Received Date: 09/13/2024
• Supplement Report FDA Received Date: 07/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/13/2023
• 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