MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS/ECLIPSE ORIEN PIN FOR RESECT GD; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	UNIVERS/ECLIPSE ORIEN PIN FOR RESECT GD
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/14/2021
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
It was reported during during a hemi shoulder arthroplasty procedure, the version rod broke off the ar-9401-13 head cut guide.The threaded portion of the version rod is now stuck inside the guide.The case was still successful and no harm was done.See attached images.Additional information received on 5/26/2021: the rep provided the part number of the version rod that broke during the procedure (ar-9202).The version rod broke while the guide was in use.The rods are threaded into the top of the guide, and are not directly in the patient but above the humerus.

• Brand Name: UNIVERS/ECLIPSE ORIEN PIN FOR RESECT GD
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11990877
• Report Number: 1220246-2021-03263
• Device Sequence Number: 3564723
• Product Code: LXH
• UDI-Device Identifier: 00888867058224
• UDI-Public: 00888867058224
• 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
• Report Date (Section B): 06/14/2021

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: UNIVERS/ECLIPSE ORIEN PIN FOR RESECT GD
• Device Catalogue Number: AR-9202
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2021
• Initial Report FDA Received Date: 06/14/2021
• Patient Sequence Number: 1