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

Model Number	DRILL BIT, 2.0MM (AO)
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/14/2024
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.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On the 15th february 2024 it was advised by a sales rep that an ar-8944-22, (drill bit, 2.0 mm) - batch# unknown was reported as the surgeon was using the 2mm drill and it snapped off inside the drill hole when drilling to insert a 3mm cortex screw in a maxforce plate.There was a case and patient involvement.
Additional Manufacturer Narrative
Since the complaint device was not returned, a physical evaluation of the device was not performed.However, the complaint allegation is not confirmed without the device being returned or any photos provided.The most likely cause for the reported failure can be attributed to improper bone prep; misaligned insertion; prying/leveraging the device during insertion.

• Brand Name: DRILL BIT, 2.0MM (AO)
• Common Device Name: DRILL BIT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 18826105
• Report Number: 1220246-2024-01254
• Device Sequence Number: 7935371
• Product Code: HTW
• UDI-Device Identifier: 00888867052840
• UDI-Public: 00888867052840
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2024

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: DRILL BIT, 2.0MM (AO)
• Device Catalogue Number: AR-8944-22
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2024
• Supplement Date Received by Manufacturer: 08/09/2024
• Initial Report FDA Received Date: 03/04/2024
• Supplement Report FDA Received Date: 09/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown