MAUDE Adverse Event Report: ARTHREX, INC. TIGHTROPE BUTTON EXTENDER; PIN, FIXATION, SMOOTH

Model Number	TIGHTROPE BUTTON EXTENDER
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/31/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2022, it was reported by a distributor via email that an ar-1589rt tightrope button extender disengaged from the tightrope at some point between the procedure and the post operative.The case was completed successfully and the button remains inside the patient without issues.This was discovered during a post operative x-ray from an acl procedure.Surgeon does not think that patient will require a revision 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.

• Brand Name: TIGHTROPE BUTTON EXTENDER
• Common Device Name: PIN, FIXATION, SMOOTH
• 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: vik bajnath ; 8009337001
• MDR Report Key: 14742797
• Report Number: 1220246-2022-05099
• Device Sequence Number: 4677131
• Product Code: HTY
• UDI-Device Identifier: 00888867019812
• UDI-Public: 00888867019812
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K110123
• 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): 06/20/2022

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: TIGHTROPE BUTTON EXTENDER
• Device Catalogue Number: AR-1589RT
• Device Lot Number: 14563903
• 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: 06/20/2022
• Date Device Manufactured: 11/18/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown