MAUDE Adverse Event Report: ARTHREX, INC. TIGHTROPE ABS, IMPLANT, OPEN; SMOOTH FIXATION PIN

Model Number	TIGHTROPE ABS, IMPLANT, OPEN
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2024
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 6/28/2024, it was reported by a facility representative via email that two ar-1588tn-1 tightrope abs converted incorrectly.This was discovered during a procedure on (b)(6) 2024.Additional information was requested.
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 7/24/2024: this was discovered on the back table during an allograft acl reconstruction with quadlink procedure.The tightrope didn't convert correctly.One-half of the tightrope would not loosen or tighten, it was just a continuous loop that would slide.Both tightropes did the exact same thing.Nothing broke in the patient.The case was completed using another ar-1588tn-1 tightrope abs.The case was delayed approximately twenty minutes; however, it's unknown if additional anesthesia was administered.The patient suffered no negative effects on or after the procedure.
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 during suture passing/tightening/tensioning.

• Brand Name: TIGHTROPE ABS, IMPLANT, OPEN
• 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: 19817607
• Report Number: 1220246-2024-06877
• Device Sequence Number: 15623016
• Product Code: MBI
• UDI-Device Identifier: 00888867019713
• UDI-Public: 00888867019713
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K231857
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/13/2025

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 Expiration Date: 10/31/2025
• Device Model Number: TIGHTROPE ABS, IMPLANT, OPEN
• Device Catalogue Number: AR-1588TN-1
• Device Lot Number: 12076216
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2024
• Supplement Date Received by Manufacturer: 07/24/2024; 06/06/2025
• Initial Report FDA Received Date: 07/24/2024
• Supplement Report FDA Received Date: 08/21/2024; 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2020
• 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