MAUDE Adverse Event Report: ARTHREX, INC. MINI TIGHTROPE IMPLANT WITH INSERTER; WASHER, BOLT, NUT

Model Number	MINI TIGHTROPE IMPLANT WITH INSERTER
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.Device was not returned and no photos were provided.Based off the information provided, the most likely cause for the reported failure can be attributed to user error of the device due to excessive force being used when tensioning the sutures.
Event or Problem Description
On 3/6/2023, it was reported by a distributor via email that an ar-8913ds mini tightrope sutures unraveled and break during tensioning.During surgery, two incisions are made, making the first dorsal approach over the entocuneiforms joint.The second approach is made along the medial cuneiform.A reduction clamp is placed to compress and reduce the base of the second metatarsal and the medial cuneiform while traction is applied to the medial column.The medial starting point of the 1.2mm guidewire is located on the medial cuneiform distal to the anterior tibialis insertion in the midcoronal plane.The guidewire is directed, assisted by fluoroscopy, toward the base of the second metatarsal in the midcoronal plane, distal to the second tmt joint, between the second and third metatarsals.The 2.7 mm cannulated drill is advanced over the guidewire.The mini tightrope with handled inserter is passed from medial to lateral.The button is flush with the lateral cortex of the second metatarsal base.When starting the adjustment of the mini tightrope by pulling the free sutures, they unravel, breaking without being able to finish the adjustment and fixation of the button.A second ar-8913ds mini tightrope is opened and the same thing happened.Case was completed by securing the second ar-8913ds mini tightrope with a #2 fiberwire.This was discovered during a lisfranc injury procedure on (b)(6) 2023.Additional information requested.

• Brand Name: MINI TIGHTROPE IMPLANT WITH INSERTER
• 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: 19480278
• Report Number: 1220246-2024-05121
• Device Sequence Number: 20589421
• Product Code: HTN
• UDI-Device Identifier: 00888867048874
• UDI-Public: 00888867048874
• Combination Product (Y/N): N
• Initial Reporter Country: PE
• PMA/510(K) Number: K133275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/06/2024

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: MINI TIGHTROPE IMPLANT WITH INSERTER
• Device Catalogue Number: AR-8913DS
• Device Lot Number: 14937140
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2022
• 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