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	Insufficient Information (4580)
Date of Event	10/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6)2022, it was reported by a sales representative via sems that a ar-9401-17 humeral head extractor chipped.This occurred during an eclipse procedure while removing the humeral head the end of it chipped.The component was removed using a standard osteotome, and the case was completed.There was no patient effect reported.
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.
Additional Manufacturer Narrative
The complaint is confirmed.One unpackaged ar-9401-17 eclipse humeral head extractor, batch number: 052202, was received for investigation.The visual evaluation confirms the instrument tip had broken off.Also, signs of wear and discoloration spots were observed on the instrument.The causes remain undetermined.The observed condition is most likely the result of interference between the device and other instrumentation or bone during use.

• 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: 15698293
• Report Number: 1220246-2022-05675
• Device Sequence Number: 8192929
• Product Code: MDM
• UDI-Device Identifier: 00888867060333
• UDI-Public: 00888867060333
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 01/04/2023

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
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2022
• Supplement Date Received by Manufacturer: 10/12/2022
• Initial Report FDA Received Date: 10/31/2022
• Supplement Report FDA Received Date: 01/04/2023
• 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