MAUDE Adverse Event Report: ARTHREX, INC. .045" GUIDE WIRE TROCAR, THREADED; ACCESSORIES, ARTHROSCOPIC

Model Number	.045" GUIDE WIRE TROCAR, THREADED
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/04/2018
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 device was reported to have been discarded.The cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported that during a dip case, the tip of the guidewire broke off.The rep was not in the case and had no more info.He was unsure if it had been retrieved.Additional information obtained 9/7/18: case was a scaphoid fix.As the guidewire was being removed it was noticed that the top was broken.The guidewire was an ar-8737-42, lot 810382544.Additional information obtained 9/11/18: it has been confirmed that the tip of the device was not retrieved as it was too deeply in the scaphoid to retrieve.It was found and confirmed under fluoro.The remaining portion of the device was disposed of after the case.The break occurred just behind the threads so no threads were visible after the main part of the guidewire was removed.

• Brand Name: .045" GUIDE WIRE TROCAR, THREADED
• Common Device Name: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7889531
• Report Number: 1220246-2018-00650
• Device Sequence Number: 2507516
• Product Code: NBH
• UDI-Device Identifier: 00888867127203
• UDI-Public: 00888867127203
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/19/2018

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 Model Number: .045" GUIDE WIRE TROCAR, THREADED
• Device Catalogue Number: AR-8737-42
• Device Lot Number: 810382544
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2018
• Initial Report FDA Received Date: 09/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1