MAUDE Adverse Event Report: ARTHREX, INC. KNOTLESS T-ROPE SYN-DESMOSIS REPR KIT,SS; WASHER, BOLT, NUT

Model Number	KNOTLESS T-ROPE SYN-DESMOSIS REPR KIT,SS
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/27/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for evaluation; no pictures were provided.The most likely cause for the reported failure can be attributed to improper bone prep; misaligned insertion; prying/leveraging the device during insertion; however, due to the device not being returned, we are unable to confirm the reported event.
Event or Problem Description
On 5/31/2022, it was reported by a sales representative via phone that while using (2) ar-8926t knotless tightrope syndesmosis repair implant system, the sutures broke consecutively while cinching down.Everything was removed from the patient and surgeon opened an ar-8926ss knotless tightrope syndesmosis repair implant system.At this point, the same thing happened, the suture broke while tensioning and cinching down.Surgeon was able to complete the case with another ar-8926ss knotless tightrope syndesmosis repair.This was discovered during an ankle fracture on (b)(6) 2022.

• Brand Name: KNOTLESS T-ROPE SYN-DESMOSIS REPR KIT,SS
• 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: 18418697
• Report Number: 1220246-2023-09771
• Device Sequence Number: 7867110
• Product Code: HTN
• UDI-Device Identifier: 00888867049079
• UDI-Public: 00888867049079
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K043248
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 12/29/2023

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: KNOTLESS T-ROPE SYN-DESMOSIS REPR KIT,SS
• Device Catalogue Number: AR-8926SS
• Device Lot Number: 25812
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2022
• Initial Report FDA Received Date: 12/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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