MAUDE Adverse Event Report: ARTHREX, INC. STEP DRILL, 2.4MM, BIO-SUTURETAK; DRILL BIT

Model Number	STEP DRILL, 2.4MM, BIO-SUTURETAK
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 09-feb-2026, it was reported by a sales representative via (b)(4) that (qty.2) of an ar-1934d-24 step drills broke.The surgeon had the tip of the drill bit break off at the stepped section.He was not torquing the drill, and it was running at full speed forward.Despite what appeared to be proper technique, both drills still broke.This was discovered during the case with no patient harm.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: STEP DRILL, 2.4MM, BIO-SUTURETAK
• 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: 24474728
• Report Number: 1220246-2026-01083
• Device Sequence Number: 9581412
• Product Code: HTW
• UDI-Device Identifier: 00888867024045
• UDI-Public: 00888867024045
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• 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): 06/15/2026

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: STEP DRILL, 2.4MM, BIO-SUTURETAK
• Device Catalogue Number: AR-1934D-24
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 02/09/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2026
• Supplement Date Received by Manufacturer: 06/12/2026
• Initial Report FDA Received Date: 02/27/2026
• Supplement Report FDA Received Date: 06/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown