MAUDE Adverse Event Report: ARTHREX, INC. MINI TIGHTROPE REPAIR; WASHER, BOLT, NUT

Model Number	MINI TIGHTROPE REPAIR
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/12/2023
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.The complaint device was not received for evaluation.Based off the information provided, the most likely cause for the reported failure can be attributed to improper bone prep; misaligned insertion; prying/leveraging the device during insertion.
Event or Problem Description
On 4/19/2023 it was reported by a distributor via email that the sutures from an ar-8911ds mini tightrope repair kit broke during reduction.This was discovered during a lisfranc procedure on (b)(6) 2023.The case was completed by removing everything from inside the patient and using a new ar-8911ds mini tightrope kit.

• Brand Name: MINI TIGHTROPE REPAIR
• 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: 19510883
• Report Number: 1220246-2024-05556
• Device Sequence Number: 14316633
• Product Code: HTN
• UDI-Device Identifier: 00888867048805
• UDI-Public: 00888867048805
• Combination Product (Y/N): N
• Initial Reporter Country: PE
• PMA/510(K) Number: K133275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/11/2024

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 REPAIR
• Device Catalogue Number: AR-8911DS
• Device Lot Number: 26926
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2023
• Initial Report FDA Received Date: 06/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown