MAUDE Adverse Event Report: ARTHREX, INC. ECLIPSE HUMERAL HEAD EXTRACTOR; MANUAL INSTR, GENERAL SURGICAL

Model Number	ECLIPSE HUMERAL HEAD EXTRACTOR
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2024
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 10/21/2024, it was reported by a sales representative via (b)(4) that an ar-9401-17 arthrex eclipse¿ humeral head extractor broke off.This occurred during an eclipse total shoulder arthroplasty procedure the head extractor broke off when removing the trial head and the fragment was retrieved.
Additional Manufacturer Narrative
Complaint allegation is confirmed.Upon visual inspection, it was noted that the tip of the arthrex eclipse¿ humeral head extractor had broken off.Functional testing was not performed due to the damage to the device.The most likely causes for this type of issue/occurrence are prying/levering the device against other instrumentation during use.

• Brand Name: ECLIPSE HUMERAL HEAD EXTRACTOR
• 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: 20630084
• Report Number: 1220246-2024-08441
• Device Sequence Number: 18178691
• Product Code: MDM
• UDI-Device Identifier: 00888867060333
• UDI-Public: 00888867060333
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 02/04/2025

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 HUMERAL HEAD EXTRACTOR
• Device Catalogue Number: AR-9401-17
• Device Lot Number: 052145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2024
• Supplement Date Received by Manufacturer: 01/07/2025
• Initial Report FDA Received Date: 11/07/2024
• Supplement Report FDA Received Date: 02/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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