MAUDE Adverse Event Report: ARTHREX, INC. DYNANITE STAPLE DRILL BIT, CAL, 2.0; BIT, DRILL

Model Number	DYNANITE® STAPLE DRILL BIT, CAL, 2.0
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/15/2021
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.
Event or Problem Description
It was reported that the tip of the ar-8717d-02 drill bit broke off during use.The sales rep reported all fragments were fully retrieved and the case was completed as planned.

• Brand Name: DYNANITE STAPLE DRILL BIT, CAL, 2.0
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11626978
• Report Number: 1220246-2021-02835
• Device Sequence Number: 3015007
• Product Code: HTW
• UDI-Device Identifier: 00888867326200
• UDI-Public: 00888867326200
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 04/07/2021

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: DYNANITE® STAPLE DRILL BIT, CAL, 2.0
• Device Catalogue Number: AR-8717D-02
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2021
• Initial Report FDA Received Date: 04/07/2021
• Patient Sequence Number: 1