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

Model Number	EASY-OUT, MICRO COMPRESSION FT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2024
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 12/10/2024, it was reported by a sales representative via (b)(4) that an ar-8737-61 screw remover, easy-out, 2.5 micro compression ft had the tip break (from their headless compression screw set #3).This was discovered during a procedure, with no report of patient harm.Additional information has been requested.
Additional Manufacturer Narrative
Correction: h1 to n/a.Arthrex previously submitted this event as a reportable malfunction out of an abundance of caution.Upon receiving additional information from the field that clarified the event, it has been determined that this event does not meet the criteria of a reportable event under 21 cfr 803.Additional information: b5, h3, h6.
Event or Problem Description
Additional information was received on 01/21/2025: the device did not break in the patient.The piece broke on the back table after use.All fragments were obtained.The case was completed by removing the screw with the screw remover.The screw remover then broke off after the screw was removed.There was no case delay.This was discovered during hardware removal on (b)(6) 2025, with no patient involvement.Additional information was requested.

• Brand Name: EASY-OUT, MICRO 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: 21084157
• Report Number: 1220246-2025-09227
• Device Sequence Number: 6899415
• Product Code: LXH
• UDI-Device Identifier: 00888867263802
• UDI-Public: (01)00888867263802(11)190815(10)1391932
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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,Followup
• Report Date (Section B): 02/12/2025

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, MICRO COMPRESSION FT
• Device Catalogue Number: AR-8737-61
• Device Lot Number: 1391932
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/06/2025
• Supplement Report FDA Received Date: 02/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/15/2019
• 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