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	01/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is now reportable.During returned device evaluation, a reportable malfunction was discovered.Complaint confirmed, the tip of the device was found to be damaged.A fragment broke off and was not returned.The cause of the event is undetermined, however the likeliest cause of the observed failure mode is user-applied mechanical forces.
Event or Problem Description
It was reported that the ar-9401-17 humeral head extractor is damaged.Additional information received on 1/27/2021: the rep reported damage to the device did not happen during a case.The issue was noticed by a sterile processing tech during inspection prior to a case.This is now reportable.During returned device evaluation, a reportable malfunction was discovered.Complaint confirmed, the tip of the device was found to be damaged.A fragment broke off and was not returned.The cause of the event is undetermined, however the likeliest cause of the observed failure mode is user-applied mechanical forces.

• 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
• MDR Report Key: 11475095
• Report Number: 1220246-2021-02705
• Device Sequence Number: 3844132
• Product Code: MDM
• UDI-Device Identifier: 00888867060333
• UDI-Public: 00888867060333
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 03/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 250150304
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2021
• Initial Report FDA Received Date: 03/12/2021
• Patient Sequence Number: 1