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	10/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a syndesmosis repair surgery the tape broke while tightening.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
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint is confirmed.Visual evaluation revealed two torn edges on one suture of the assembly.The round button was not received with the assembly.Functional testing could not be 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 excessive force used during suture tensioning.

• 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: emily shafer ; 8009337001
• MDR Report Key: 18083636
• Report Number: 1220246-2023-08592
• Device Sequence Number: 12729994
• Product Code: HTN
• UDI-Device Identifier: 00888867265608
• UDI-Public: 00888867265608
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2024

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: 25862
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2023
• Supplement Date Received by Manufacturer: 03/28/2024
• Initial Report FDA Received Date: 11/07/2023
• Supplement Report FDA Received Date: 11/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2022
• 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