MAUDE Adverse Event Report: ARTHREX, INC. THRDED G-WIRE,W/TRCR TIP,.062"; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	THRDED G-WIRE,W/TRCR TIP,.062"
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/23/2019
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 remaining portion of the device was reported to have been discarded.The root cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported during a lisfranc procedure, the ar-8941kt threaded guidewire with trocar tip was used as provisional point of fixation.As the surgeon removed the guidewire, it came out missing the threaded tip.The surgeon decided to leave the tip in the bone, as it was mid-shaft and not capable of migration.Additional information received on 05/15/2019: the agency confirmed the lot number of the complaint device is unknown.The rep stated the surgeon used multiple instruments in attempt to extract the broken fragment, but the fragment was buried in the bone midshaft and could not be retrieved.The surgeon concluded that there was no chance of migration, and that retrieving the piece would cause more harm to the patient then leaving it implanted.The remaining shaft of the guidewire was discarded by the facility and will not be returning for evaluation.

• Brand Name: THRDED G-WIRE,W/TRCR TIP,.062"
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8611789
• Report Number: 1220246-2019-01098
• Device Sequence Number: 13954017
• Product Code: LXH
• UDI-Device Identifier: 00888867051843
• UDI-Public: 00888867051843
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/15/2019

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 Model Number: THRDED G-WIRE,W/TRCR TIP,.062"
• Device Catalogue Number: AR-8941KT
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2019
• Initial Report FDA Received Date: 05/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other