MAUDE Adverse Event Report: ACUMED LLC 36MM, 3.5 MINI ACUTRAK 3® BONE SCREW; SCREW, FIXATION, BONE

Model Number	3052-35036
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One driver was returned broken.Only the main body portion of the driver was returned (tip portion not returned); evaluation will be for the main body.A bone screw was mentioned in the incident but was not returned (cannot examine).Driver was examined under magnification.Driver exhibits a fracture region which sits obliquely to the device axis.Surfaces of the fracture region are lightly textured and not sharp to touch.Signs of ductility are not present at the fracture site (e.G.Necking).A measurement of the overall returned body length was taken.No definitive conclusions can be made.Related report (including this one): 3025141-2026-00083.
Event or Problem Description
It was reported that upon insertion of the screw, the driver tip shattered into 3-5 pieces.The doctor did not appear to be applying excessive torque.A new driver tip was used to finish screw insertion.

• Brand Name: 36MM, 3.5 MINI ACUTRAK 3® BONE SCREW
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ACUMED LLC; 5885 ne cornelius pass road; hillsboro
• Manufacturer (Section G): ACUMED LLC; 5885 ne cornelius pass road; hillsboro OR 97124
• Manufacturer Contact: aram tran ; 5885 ne cornelius pass road; hillsboro, OR 97124
• MDR Report Key: 24328644
• Report Number: 3025141-2026-00084
• Device Sequence Number: 13147034
• Product Code: HWC
• UDI-Device Identifier: 10806378120985
• UDI-Public: 10806378120985
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K230744
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/12/2026

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: 3052-35036
• Device Catalogue Number: 3052-35036
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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