MAUDE Adverse Event Report: ARTHREX, INC. DUAL TRIGGER ROTARY DRILL; POWERED SURG ORTHOPEDIC INSTR

Model Number	DUAL TRIGGER ROTARY DRILL
Medical Device Problem Code	Failure to Auto Stop (2938)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2025
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 16-dec-2025, it was reported by a sales representative via (b)(4) that an ar-01-01-001 dual trigger rotary drill continued to run even though the trigger was no longer engaged.This was discovered during the case.Another device was used to complete the case with no patient harm.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint allegation was not confirmed.The reported failure couldn't be recreated.One unpackaged ar-01-01-001 serial number (b)(6), batch number 15444282, was received for evaluation.Visual inspection noted normal wear and tear on the device.Functional testing was performed by connecting the device to a known-good li-ion battery.The device works as intended and does not display any stuck triggers or continue to run after the trigger has been disengaged.Further evaluation was performed by the engineering team.The results of the investigation are as follows: the complaint allegation was not confirmed.Hall output values were analyzed through serial comm tools and found to be within normal range and the device performed as intended when connected to a battery.The bottom of the handpiece was opened and found fasteners to be fully seated.The device was sent to amie for imaging and found no signs of controller shift.The device was then sent to cmi for analysis.Cmi found no signs of controller defects or related issues.Root cause(s): no signs of failure on received device.The field should be monitored for a possible trend.

• Brand Name: DUAL TRIGGER ROTARY DRILL
• Common Device Name: POWERED SURG ORTHOPEDIC INSTR
• 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: 23957762
• Report Number: 1220246-2026-00042
• Device Sequence Number: 13123650
• Product Code: HWE
• UDI-Device Identifier: 00888867458352
• UDI-Public: (01)00888867458352(11)250530(10)15444282
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 04/30/2026

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: DUAL TRIGGER ROTARY DRILL
• Device Catalogue Number: AR-01-01-001
• Device Lot Number: 15444282
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2025
• Supplement Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/30/2025
• 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