MAUDE Adverse Event Report: ARTHREX, INC. DRILL BIT, MINI AO, 1.2MM, CALIBRATED; BIT, DRILL

Model Number	DRILL BIT, MINI AO, Ø1.2MM, CALIBRATED
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/23/2021
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 ar-18700-12 drill bit broke about one cm up from the tip.
Additional Manufacturer Narrative
It was reported that the drill broke.The reported event is confirmed upon investigation of the returned picture.Visual evaluation identified that the drill bit had fractured towards the distal end of the device.However, without the return of the device, further investigation cannot be performed.The root cause of the reported failure mode is undetermined.However, the most likely probable cause is applying excessive mechanical forces upon insertion.

• Brand Name: DRILL BIT, MINI AO, 1.2MM, CALIBRATED
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11484731
• Report Number: 1220246-2021-02741
• Device Sequence Number: 3844138
• Product Code: HTW
• UDI-Device Identifier: 00888867312678
• UDI-Public: 00888867312678
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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,Followup
• Report Date (Section B): 09/07/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: DRILL BIT, MINI AO, Ø1.2MM, CALIBRATED
• Device Catalogue Number: AR-18700-12
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/25/2021
• Supplement Date Received by Manufacturer: 02/25/2021
• Initial Report FDA Received Date: 03/15/2021
• Supplement Report FDA Received Date: 09/07/2021
• Patient Sequence Number: 1