MAUDE Adverse Event Report: ARTHREX, INC. ECLIPSE RESECT PROTECTOR,SZ S/40.0MM; ORTHOPEDIC MANUAL SURG INSTR

Model Number	ECLIPSE RESECT PROTECTOR,SZ S/40.0MM
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2024
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 09/23/2024, a sales representative reported via (b)(6) that (qty.4) of an ar-9401-40 arthrex eclipse resection protector, size s / 40 mm, was stripping away.This was discovered during a procedure, and no patient harm was reported.Additional information has been requested.
Event or Problem Description
Additional information was received on 09/26/2024: this was discovered during an unspecified procedure on (b)(6) 2024.The device did not break, and no debris was produced.There was no case delay.The case was completed successfully, and the devices were not needed anymore after the issue was noticed.There were no adverse effects on the patient.
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 is wear and tear incurred over repeated use.

• Brand Name: ECLIPSE RESECT PROTECTOR,SZ S/40.0MM
• 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: 20343390
• Report Number: 1220246-2024-07905
• Device Sequence Number: 8023882
• Product Code: LXH
• UDI-Device Identifier: 00888867060364
• UDI-Public: 00888867060364
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Followup
• Report Date (Section B): 07/07/2025

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 RESECT PROTECTOR,SZ S/40.0MM
• Device Catalogue Number: AR-9401-40
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2024
• Supplement Date Received by Manufacturer: Not provided; 06/10/2025
• Initial Report FDA Received Date: 10/01/2024
• Supplement Report FDA Received Date: 10/09/2024; 07/07/2025
• 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