MAUDE Adverse Event Report: ACUMED, LLC 2.3MM X 16MM LOCKING CORTICAL SCREW; SCREW, FIXATION, BONE

Model Number	CO-T2316
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the surgeon was inserting a screw and the tip of the 80-0728 driver broke.
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.Related report numbers (including this report): 3025141-2025-00496 3025141-2025-00497 3025141-2025-00498.

• Brand Name: 2.3MM X 16MM LOCKING CORTICAL SCREW
• Common Device Name: SCREW, FIXATION, BONE
• 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: 23291825
• Report Number: 3025141-2025-00499
• Device Sequence Number: 4863912
• Product Code: HWC
• UDI-Device Identifier: 10806378062407
• UDI-Public: 10806378062407
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• PMA/510(K) Number: K233311
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/14/2025

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: CO-T2316
• Device Catalogue Number: CO-T2316
• Device Lot Number: 662896
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2025
• Initial Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/20/2025
• 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