MAUDE Adverse Event Report: ARTHREX, INC. ACL TIGHTROPE RT W/ DEPLOYING SUTURE; SMOOTH FIXATION PIN

Model Number	ACL TIGHTROPE RT W/ DEPLOYING SUTURE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2024
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 (b)(6) 2024, it was reported by an arthrex subsidiary employee via ar-1588rt-j acl tightrope rt sutures broke, and the graft became loose.The suture came off the chinese finger trap.A new product was used to complete the case.This was discovered during a procedure on (b)(6) 2024.Additional information received on 7/8/2024: this was discovered during an aclr procedure.This occurred when the graft was being implanted.The case was completed using a new ar-1588rt-j acl tightrope rt.The case was briefly delayed; however, additional anesthesia was not administered.The patient suffered no negative effects on or after the procedure.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 complaint is confirmed.Upon visual inspection, it was noted that the suture tightrope rt was broken, and the white and black suture was not returned for investigation.Functional testing was not performed due to the damage to the device.The most likely cause of the reported failure can be attributed to user error of the device due to either excessive force used during suture passing or the device coming in contact with another device during use.

• Brand Name: ACL TIGHTROPE RT 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: 19819448
• Report Number: 1220246-2024-06889
• Device Sequence Number: 8709299
• Product Code: MBI
• UDI-Device Identifier: 00888867095533
• UDI-Public: 00888867095533
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2025

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: ACL TIGHTROPE RT W/ DEPLOYING SUTURE
• Device Catalogue Number: AR-1588RT-J
• Device Lot Number: 15155699
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2024
• Supplement Date Received by Manufacturer: 01/02/2025
• Initial Report FDA Received Date: 07/24/2024
• Supplement Report FDA Received Date: 01/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2023
• 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