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 Code	Insufficient Information (4580)
Date of Event	08/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a revision surgery of a shoulder prosthesis; it was not possible to use the ar-9401-17 in the notches as usual.Instead, the implant had to be broken up and the extraction instrument broke.All broken parts were retrieved from the patient.In addition, ar-9545-t15-02 was worn out on arrival.The device could be used during surgery but should not be used again.The surgery was finished successfully with the same devices.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The reported event was confirmed as one unpackaged ar-9401-17, eclipse humeral head extractor, batch number 052450, was received for investigation and the visual inspection revealed that the cutting edge of the tip had nicks and was bent, deforming the geometry of the tip (see evaluation pictures 3 + 4).No fragments were returned for evaluation.Functional testing was not performed due to the damage of 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: 22998588
• Report Number: 1220246-2025-03751
• Device Sequence Number: 9469019
• Product Code: MDM
• UDI-Device Identifier: 00888867060333
• UDI-Public: (01)00888867060333(11)250205(10)052450
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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): 11/11/2025

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: 052450
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 08/18/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2025
• Supplement Date Received by Manufacturer: 11/11/2025
• Initial Report FDA Received Date: 09/08/2025
• Supplement Report FDA Received Date: 11/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/05/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown