MAUDE Adverse Event Report: Arthrex, Inc. TIGHTROPE SUTURE TENSIONER; ORTHOPEDIC MANUAL SURG INSTR

Model Number	TIGHTROPE SUTURE TENSIONER
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a surgery the device showed signs of wear and tear.The customer reports that they are requesting a replacement of the instrument due to wear and tear over time.Per complaint reporter there was no harm for patient, operator or third party.No further information received.***update 17-sep-2026 it was further reported that the event occurred during the surgical procedure.While using the instruments, the surgeon applied slightly increased force to tension the tensioning devices.As a result, the tensioning device fractured and a portion of a suture remained inside the patient; however, it was successfully retrieved without complications.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: TIGHTROPE SUTURE TENSIONER
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• 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: 50945083
• Report Number: 1220246-2026-04958
• Device Sequence Number: 13145163
• Product Code: MDM
• UDI-Device Identifier: 00888867019546
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: EXEMPT
• 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): 09/30/2026

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: TIGHTROPE SUTURE TENSIONER
• Device Catalogue Number: AR-1588H
• Device Lot Number: 37621816
• 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: 09/10/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/28/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown