MAUDE Adverse Event Report: ARTHREX, INC. BANANA SUTURELASSO; ORTHOPEDIC MANUAL SURG INSTR

Model Number	BANANA SUTURELASSO
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2022
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 is confirmed.(1) unpackaged ar-4065b was received for investigation.Visual inspection revealed that component ar-4065-015, the nitinol wire loop, was broken before the welded end, resulting in an open loop.No obstruction was found in the device's lumen, and the wire was capable of passing through without resistance.Without additional information about the device's usage, the most likely cause for the reported failure can be attributed to user error of the device due to prying/leveraging the screw during insertion and/or improper bone preparation.
Event or Problem Description
It was reported that during a surgery the wire could not be moved through.There was no harm for patient, operator or third party reported.The surgery was finished successfully with a new device from another manufacturer.It was not necessary to switch the surgical technique or do a second surgery.Update 11-may-2022 dw the reported device was returned with a note from the customer that the wire was torn.

• Brand Name: BANANA SUTURELASSO
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• 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: 19351560
• Report Number: 1220246-2024-03510
• Device Sequence Number: 20653313
• Product Code: LXH
• UDI-Device Identifier: 00888867031371
• UDI-Public: 00888867031371
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/20/2024

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: 04/30/2026
• Device Model Number: BANANA SUTURELASSO
• Device Catalogue Number: AR-4065B
• Device Lot Number: 1111111785
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2022
• Initial Report FDA Received Date: 05/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2021
• 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