MAUDE Adverse Event Report: ARTHREX, INC. EASY-OUT, MINI/STANDARD COMPRESSION FT; ORTHOPEDIC MANUAL SURG INSTR

Model Number	EASY-OUT, MINI/STANDARD COMPRESSION FT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a lapidus surgery the tip of the screw remover broke when trying to remove a broken screw.The surgery was finished successfully with the same screw remover.It was not necessary to switch the surgical technique or do a second surgery.Update avoe 15-dec-2023: the batch number for the ar-8737-62 was provided (1391942).
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.
Additional Manufacturer Narrative
Complaint allegation is not confirmed.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause of this failure is attributed to wear and tear damage incurred over repeated usage.Manufactured date 2019.

• Brand Name: EASY-OUT, MINI/STANDARD COMPRESSION FT
• 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: emily shafer ; 8009337001
• MDR Report Key: 18437325
• Report Number: 1220246-2024-00046
• Device Sequence Number: 20778657
• Product Code: LXH
• UDI-Device Identifier: 00888867263833
• UDI-Public: 00888867263833
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• 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,Followup
• Report Date (Section B): 02/06/2025

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: EASY-OUT, MINI/STANDARD COMPRESSION FT
• Device Catalogue Number: AR-8737-62
• Device Lot Number: 1391942
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2023
• Supplement Date Received by Manufacturer: 01/14/2025
• Initial Report FDA Received Date: 01/03/2024
• Supplement Report FDA Received Date: 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2019
• 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