MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS/ECLIPSE ORIEN PIN FOR RESECT GD; ORTHOPEDIC MANUAL SURG INSTR

Model Number	UNIVERS/ECLIPSE ORIEN PIN FOR RESECT GD
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2026
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 (b)(6), it was reported by a sales representative via sems-(b)(4) that an ar-9202 pin was struck with a mallet when removing and snapped.Noticed during a case with no patient effect.

• Brand Name: UNIVERS/ECLIPSE ORIEN PIN FOR RESECT GD
• 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: 24618063
• Report Number: 1220246-2026-01457
• Device Sequence Number: 15846887
• Product Code: LXH
• UDI-Device Identifier: 00888867058224
• UDI-Public: (01)00888867058224(11)210304(10)AR07002201
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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): 07/08/2026

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: UNIVERS/ECLIPSE ORIEN PIN FOR RESECT GD
• Device Catalogue Number: AR-9202
• Device Lot Number: AR07002201
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2026
• Supplement Date Received by Manufacturer: 07/02/2026
• Initial Report FDA Received Date: 03/17/2026
• Supplement Report FDA Received Date: 07/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/04/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown