MAUDE Adverse Event Report: ARTHREX, INC. ECLIPSE & UNIVERS II RESECT GD L,RT; MANUAL INSTR, GENERAL SURGICAL

Model Number	ECLIPSE & UNIVERS II RESECT GD L,RT
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2025
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
It was reported that during a surgery apparently the holes were so deformed that only 1.6 k-wires could fit through.In one hole the wire broke off and became stuck.There was no harm for patient, operator or third party reported.No further information received.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.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 for the reported failure can be attributed to misuse/mishandling due to the damage to the device.

• Brand Name: ECLIPSE & UNIVERS II RESECT GD L,RT
• Common Device Name: MANUAL INSTR, GENERAL SURGICAL
• 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: 21304117
• Report Number: 1220246-2025-00155
• Device Sequence Number: 12799776
• Product Code: MDM
• UDI-Device Identifier: 00888867060326
• UDI-Public: (01)00888867060326(10)250060901
• 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,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2025

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: ECLIPSE & UNIVERS II RESECT GD L,RT
• Device Catalogue Number: AR-9401-13
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2025
• Supplement Date Received by Manufacturer: 10/20/2025
• Initial Report FDA Received Date: 02/04/2025
• Supplement Report FDA Received Date: 10/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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