MAUDE Adverse Event Report: ARTHREX, INC. DRILL BIT, MINI AO, Ø1.1MM, CALIBRATED

Model Number	DRILL BIT, MINI AO, Ø1.1MM, CALIBRATED
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 05/15/2025, a representative reported via (b)(4) that an ar-18700-06 drill bit broke into three pieces.This occurred during use; one of the pieces remains in the patient.There was no patient harm.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Complaint allegation is not confirmed.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to improper bone prep; misaligned insertion; prying/leveraging or the device coming in contact with another device during use.

• Brand Name: DRILL BIT, MINI AO, Ø1.1MM, CALIBRATED
• 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: 22293271
• Report Number: 1220246-2025-02561
• Device Sequence Number: 8319281
• Product Code: HTW
• UDI-Device Identifier: 00888867312654
• UDI-Public: (01)00888867312654(11)240628(10)022425
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 09/29/2025

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, MINI AO, Ø1.1MM, CALIBRATED
• Device Catalogue Number: AR-18700-06
• Device Lot Number: 022425
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/15/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2025
• Supplement Date Received by Manufacturer: 09/26/2025
• Initial Report FDA Received Date: 06/19/2025
• Supplement Report FDA Received Date: 09/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/28/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown