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

Model Number	ECLIPSE HUMERAL HEAD EXTRACTOR
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On 06/03/2022, it was reported by a sales representative via email that an ar-9401-17 eclipse¿ humeral head extractor broke in an unspecified procedure.This was discovered during use with no impact to the patient.Additional information has been requested.On 06/20/2022, the sales representative stated the following information via email: this event occurred during a total shoulder arthroplasty procedure on (b)(6) 2022, no attachment was used with the device.A piece broke inside the patient, and the piece was retrieved.An osteotome had to be used as a replacement, the case was completed successfully and the patient is fine to date.The complaint device was returned.
Additional Manufacturer Narrative
Visual inspection found the device broke at the distal tip of the device.Complaint was confirmed.

• Brand Name: ECLIPSE HUMERAL HEAD EXTRACTOR
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• 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: vik bajnath ; 8009337001
• MDR Report Key: 14744658
• Report Number: 1220246-2022-05118
• Device Sequence Number: 4677607
• Product Code: MDM
• UDI-Device Identifier: 00888867060333
• UDI-Public: 00888867060333
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 11/17/2022

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: 250090803
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2022
• Supplement Date Received by Manufacturer: 06/03/2022
• Initial Report FDA Received Date: 06/20/2022
• Supplement Report FDA Received Date: 11/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown