MAUDE Adverse Event Report: ARTHREX, INC. 1.3 MM DRL BIT FOR 2.0 MM QCKFIX SCRW; DRILL BIT

Model Number	1.3 MM DRL BIT FOR 2.0 MM QCKFIX SCRW
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
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 13-feb-2026, it was reported by an arthrex subsidiary employee via (b)(4) that an ar-8930d-13 1.3 mm drill bit for 2.0 mm quickfix screw bent and broke during the creation of the bone tunnel.This was discovered during an unspecified procedure with no patient harm.The surgery was completed using the other drill from the set.

• Brand Name: 1.3 MM DRL BIT FOR 2.0 MM QCKFIX SCRW
• 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: 24531334
• Report Number: 1220246-2026-01278
• Device Sequence Number: 13349813
• Product Code: HTW
• UDI-Device Identifier: 00888867049253
• UDI-Public: (01)00888867049253(11)190131(10)031904
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 06/23/2026

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: 1.3 MM DRL BIT FOR 2.0 MM QCKFIX SCRW
• Device Catalogue Number: AR-8930D-13
• Device Lot Number: 031904
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/13/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2026
• Supplement Date Received by Manufacturer: 06/19/2026
• Initial Report FDA Received Date: 03/06/2026
• Supplement Report FDA Received Date: 06/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/31/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown