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

Model Number	DUAL TRIGGER ROTARY DRILL
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2025
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 11/14/2025, a facility representative reported via (b)(4) that an ar-01-01-001 dual trigger rotary drill broke during the trial.When they pressed the power trigger, it continued to rotate during the case.They were able to pull another set out to finish with no patient impact.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint allegation was confirmed.One unpackaged ar-01-01-001 serial number (b)(6) was received for evaluation.Visual inspection noted rust on the battery connectors and normal wear and tear.Functional testing was performed by the engineering team, by attaching a known-good battery, as the device continued to run even with the trigger released.The device was connected to serial comm tools and trigger hall voltage was measured.The lower trigger voltage appeared to be larger than initial calibration indicating a change in state.The engineering team reavealed that "cmi determined that the lower hall sensor ¿focuser window¿ had become magnetized.The hall window is a ferromagnetic material which can become magnetized in a large enough magnetic field.It is unknown what caused the change as it may have happened at any point after final calibration at amisc." the most likely cause of the reported failure is due to a manufacturing issue causing the lower hall focuser window to become magnetized.

• 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: 23706107
• Report Number: 1220246-2025-05354
• Device Sequence Number: 10649521
• Product Code: HWE
• UDI-Device Identifier: 00888867458352
• UDI-Public: (01)00888867458352(11)250320(10)15407174
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2026

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: 15407174
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2025
• Supplement Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown