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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 05/29/2025, a facility representative reported via (b)(4) that an ar-8737-62 mini easy-out screw remover tip broke off during a case, and no patient was harmed.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is confirmed.Upon visual inspection, it was noted that the distal end of the shaft was broken, and the threads were damaged.Functional testing was not performed due to the damage to the device.Per dfu-0023-eo cautions: to avoid damaging the instruments, do not impact or subject to blunt force any instruments that are designed to be turned or screwed in.When two devices are intended to be threaded together, ensure that they are fully engaged prior to use.The most likely cause of the reported failure can be attributed to user error of the device due to over-torquing/over-engaging applying excessive mechanical forces during insertion/use.

• 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: jared engle ; 8009337001
• MDR Report Key: 22296588
• Report Number: 1220246-2025-02577
• Device Sequence Number: 8893191
• Product Code: LXH
• UDI-Device Identifier: 00888867263833
• UDI-Public: (01)00888867263833(11)240903(10)1392434
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2025

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: 1392434
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2025
• Supplement Date Received by Manufacturer: 07/11/2025
• Initial Report FDA Received Date: 06/20/2025
• Supplement Report FDA Received Date: 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2024
• 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