MAUDE Adverse Event Report: ARTHREX, INC. 1.8MM DRILL FOR FIBERTAK; DRILL BIT

Model Number	1.8MM DRILL FOR FIBERTAK
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On (b)(6)2025, an arthrex subsidiary employee reported via (b)(4) that an ar-3600d-2 drill broke off.The broken drill was removed and the bone hole re-drilled in another location with another product.No patient harms.Additional information requested.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint allegation was confirmed.One unpackaged ar-3600d-2 serial number, (b)(6) (laser mark on the part), was received for investigation.A functional test was not performed as the device's tip was received broken off.Visual evaluation found that the tip of the device was broken off.The small broken tip was analyzed, and it was noted that there were nicks on the threads.A user error is the most likely cause(s) for the reported and observed failure, hitting the device with another device or object, prying/leveraging, or excessive bending forces applied during use.

• Brand Name: 1.8MM DRILL FOR FIBERTAK
• 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: 21642984
• Report Number: 1220246-2025-01017
• Device Sequence Number: 15357229
• Product Code: HTW
• UDI-Device Identifier: 00888867101913
• UDI-Public: (01)00888867101913(11)240429(17)290331(10)15241330
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 07/31/2025

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: 1.8MM DRILL FOR FIBERTAK
• Device Catalogue Number: AR-3600D-2
• Device Lot Number: 15241330
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2025
• Supplement Date Received by Manufacturer: 07/23/2025
• Initial Report FDA Received Date: 03/19/2025
• Supplement Report FDA Received Date: 07/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/29/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown