MAUDE Adverse Event Report: ACUMED, LLC ACUTRAK 2® - 4.7 PROFILE DRILL; BIT, DRILL

Model Number	80-0945
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the drill broke during use.The drill was able to be extracted and is not left behind in the body.No adverse event reported, delay of 10 minutes.
Additional Manufacturer Narrative
To date, the device has not returned for evaluation, the root cause could not be established.Additional reporting on this event will be provided as a follow up report if more information becomes available.
Additional Manufacturer Narrative
One "acutrak 2® - 4.7 profile drill" was returned; only the main body portion of the broken driver was returned.The drill was examined under magnification.The cannulated drill exhibits a complex breakage, with surfaces within the fracture region sitting at varying oblique angles to the device axis; this results in a jagged fracture region.Signs of ductility are not present at the fracture site (e.G.Necking).Signs of fatigue are not present at the fracture site (e.G.Progression marks).Cutting edges of drill flutes appear to be worn or dulled.The overall length of the main body portion was measured with caliper; measured length was 4.9230 inches.No definitive conclusions can be made.

• Brand Name: ACUTRAK 2® - 4.7 PROFILE DRILL
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): ACUMED, LLC; 5885 ne cornelius pass road; hillsboro OR 97124
• Manufacturer (Section G): ACUMED LLC; 5885 ne cornelius pass road; hillsboro OR 97124
• Manufacturer Contact: kimberly banning ; 5885 ne cornelius pass road; hillsboro, OR 97124
• MDR Report Key: 23407361
• Report Number: 3025141-2025-00567
• Device Sequence Number: 9076045
• Product Code: HTW
• UDI-Device Identifier: 10806378045547
• UDI-Public: 10806378045547
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2025

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: 80-0945
• Device Catalogue Number: 80-0945
• Device Lot Number: 600549
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2025
• Supplement Date Received by Manufacturer: 11/07/2025
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 11/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown