MAUDE Adverse Event Report: ARTHREX, INC. DRILL BIT, 2.0MM (AO); BIT, DRILL

Model Number	DRILL BIT, 2.0MM (AO)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/12/2019
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 root cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported the tip of the ar-8944-22 drill bit (approximately 15-20mm) broke off while in bone during a lapidus procedure.The rep stated the broken piece was not noticed until final x-rays were being taken.The rep stated they had already left the or, but returned to the room once notified.The broken fragment remains in the patient.Additional information received on 06/17/2019: the rep stated it is unknown if the surgeon plans to perform a revision surgery to remove the fragment.The procedure was open, and there are not any portions of the drill bit available to return for evaluation.Additional information received on 06/18/2019: the rep reported that the surgeon does not currently plan on performing a second surgery.They will continue to monitor.A copy of the x-ray has been provided to arthrex.

• Brand Name: DRILL BIT, 2.0MM (AO)
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8735136
• Report Number: 1220246-2019-01173
• Device Sequence Number: 19400828
• Product Code: HTW
• UDI-Device Identifier: 00888867052840
• UDI-Public: 00888867052840
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/26/2019

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: DRILL BIT, 2.0MM (AO)
• Device Catalogue Number: AR-8944-22
• Device Lot Number: 031844
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2019
• Initial Report FDA Received Date: 06/26/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 78 YR