MAUDE Adverse Event Report: ARTHREX, INC. ACL REPAIR TIGHTROPE, WITH INTERNALBRACE; NON-DEGRADABLE FIXATN FASTENER

Model Number	ACL REPAIR TIGHTROPE, WITH INTERNALBRACE
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an anterior cruciate ligament surgery the device did not drag.According to the surgeon no harm for patient, operator or third party occurred.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.Update avoe 22-dec-2022 further information was provided about the failure and it was confirmed that the ligament couldn't be pulled up to the thigh (was not submitted).
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.Not confirmed.The device was not returned for evaluation.The most likely cause for the reported failure can be attributed to misuse/mishandling due to damage to the device.

• Brand Name: ACL REPAIR TIGHTROPE, WITH INTERNALBRACE
• Common Device Name: NON-DEGRADABLE FIXATN FASTENER
• 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: 19021102
• Report Number: 1220246-2024-01779
• Device Sequence Number: 14423158
• Product Code: MBI
• UDI-Device Identifier: 00888867363656
• UDI-Public: 00888867363656
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K202581
• 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
• Report Date (Section B): 04/02/2024

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 Expiration Date: 06/30/2026
• Device Model Number: ACL REPAIR TIGHTROPE, WITH INTERNALBRACE
• Device Catalogue Number: AR-1588R-IB
• Device Lot Number: 13775297
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2022
• Initial Report FDA Received Date: 04/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2021
• 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