MAUDE Adverse Event Report: ARTHREX, INC. PIN SET, UNIVERS II/ ECLIPSE; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Model Number	PIN SET, UNIVERS II/ ECLIPSE
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/27/2018
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reporter via fda medwatch letter (mw5083334) that during a procedure on (b)(6) 2018, "a guidewire was inserted into the scapula and in the process it broke off within the body of the scapula.Medial portion of the guide pin was encased in the cortical bone.Numerous attempts were made to retrieve the retained portion of the guidewire but ultimately the decision was made to leave it the bone." no part number was provided in the letter however the lot number provided matches in the arthrex system to part ar-9207s, pin set univers ii/eclipse.The above event description was entered by arthrex as received in the medwatch report.This event description may contain claims or language from the reporter/complainant regarding arthrex device performance.Such claims have not been evaluated by any arthrex product experts.Arthrex¿s inclusion of any claims should not be construed as arthrex expressing agreement with such claims.This complaint will be evaluated as all complaints are in accordance with arthrex complaint handling procedures.Additional information obtained 3/19/19: the sales rep has confirmed that the part number involved was ar-9207s.

• Brand Name: PIN SET, UNIVERS II/ ECLIPSE
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8432730
• Report Number: 1220246-2019-00968
• Device Sequence Number: 13766447
• Product Code: MDM
• UDI-Device Identifier: 00888867137493
• UDI-Public: 00888867137493
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/19/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: PIN SET, UNIVERS II/ ECLIPSE
• Device Catalogue Number: AR-9207S
• Device Lot Number: 10232675
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2019
• Initial Report FDA Received Date: 03/19/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other