MAUDE Adverse Event Report: ARTHREX, INC. K-LESS T-ROPE IMP ONLY, SYN REPR ,TI; WASHER, BOLT, NUT

Model Number	K-LESS T-ROPE IMP ONLY, SYN REPR ,TI
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a syndesmosis repair surgery the suture tore while tightening.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.
Additional Manufacturer Narrative
Complaint allegation is confirmed.The visual inspection identified that the white braid suture returned from the knotless tightrope® syndesmosis repair, implant only, titanium had broken, frayed, and damaged.Only the round button was returned with the white suture.Evaluation of the oblong button found no sharp edges or defects.The evaluation of the suture attached to it found that it was not frayed or damaged.Functional testing was performed by gently pulling the straight needle attached to the suture and the oblong button.The suture was noted to be firmly crimped to the needle.No problem was found.The most likely cause for the reported failure can be attributed to user error of the device due to either excessive force used during suture passing/tightening /tensioning or the device coming in contact with another device during use.

• Brand Name: K-LESS T-ROPE IMP ONLY, SYN REPR ,TI
• Common Device Name: WASHER, BOLT, NUT
• 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: 21334422
• Report Number: 1220246-2025-00308
• Device Sequence Number: 3826567
• Product Code: HTN
• UDI-Device Identifier: 00888867265608
• UDI-Public: (01)00888867265608(11)240501(17)290430(10)31050
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K043248
• 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): 04/16/2025

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: K-LESS T-ROPE IMP ONLY, SYN REPR ,TI
• Device Catalogue Number: AR-8924T
• Device Lot Number: 31050
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2025
• Supplement Date Received by Manufacturer: 04/02/2025
• Initial Report FDA Received Date: 02/07/2025
• Supplement Report FDA Received Date: 04/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2024
• 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