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

Model Number	ACL TIGHTROPE RT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2025
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 7th july 2025, it was reported by an arthrex's employee via email that for an ar-1588rt, acl tightrope® rt, the white suture broke when retrieving it.This was detected during a reconstruction of anterior cruciate ligament procedure on (b)(6) 2025.The procedure was completed successfully by using another new ar-1588rt.There was no patient harm, and no secondary procedure needed.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.One unpackaged ar-1588rt / batch 15307433 was returned for investigation.- visual evaluation revealed fraying of the blue sutures along the button.The button itself exhibited surface damage.The white sutures were not returned for investigation and, therefore, could not be evaluated.- functional testing was not performed due to the damage to the device.- 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.- refer to investigation photos.- the complaint allegation is confirmed.

• Brand Name: ACL TIGHTROPE RT
• 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: 22649676
• Report Number: 1220246-2025-03126
• Device Sequence Number: 18347024
• Product Code: MBI
• UDI-Device Identifier: 00888867019553
• UDI-Public: (01)00888867019553(11)240826(17)290731(10)15307433
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 09/30/2025

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
• Device Catalogue Number: AR-1588RT
• Device Lot Number: 15307433
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Distributor Facility Aware Date: 07/07/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2025
• Supplement Date Received by Manufacturer: 09/19/2025
• Initial Report FDA Received Date: 07/29/2025
• Supplement Report FDA Received Date: 09/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/26/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown