MAUDE Adverse Event Report: ARTHREX, INC. DRILL BIT FOR 3.5MM SWIVELOCK

Model Number	DRILL BIT FOR 3.5MM SWIVELOCK
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/03/2025
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 08/05/2025, it was reported by an arthrex subsidiary employee via (b)(4) that an ar-1678-05 drill bit for swivelock broke.This occurred during a knee arthroses plus acl where the fragment was recovered.
Event or Problem Description
Additional information was provided on 08/30/2025 where it was reported that the patient had good bone quality.There was no delay in the procedure, and it was not necessary to apply further anesthesia.
Additional Manufacturer Narrative
Additional information: b5, g3, h3, h6.Complaint allegation is confirmed by the attached picture, which shows the shaft of the drill bit for swivelock®, 3.5 mm was broken off.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.Dfu-0023-eo - i.Cautions - 2.To avoid damaging the instruments, do not impact or subject to blunt force any instruments that are designed to be turned or screwed in.When two devices are intended to be threaded together, ensure that they are fully engaged prior to use.The most likely cause for the reported failure can be attributed to misaligned insertion; prying/leveraging and/or or the device coming in contact with another device during use.

• Brand Name: DRILL BIT FOR 3.5MM SWIVELOCK
• 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: 22853153
• Report Number: 1220246-2025-03566
• Device Sequence Number: 8457574
• Product Code: HTW
• UDI-Device Identifier: 00888867020863
• UDI-Public: 00888867020863
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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): 11/18/2025

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 FOR 3.5MM SWIVELOCK
• Device Catalogue Number: AR-1678-05
• Device Lot Number: 4512225
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2025
• Supplement Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 08/20/2025
• Supplement Report FDA Received Date: 11/18/2025
• 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