MAUDE Adverse Event Report: ACUMED, LLC 2.7MM X 12MM NON-LOCKING HEXALOBE SCREW; SCREW, FIXATION, BONE

Model Number	30-0345-S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	10/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the screw head sheared off when implanting in the plate with a t8 screwdriver.The screw was left in situ and the head was disposed of.
Additional Manufacturer Narrative
To date, the device has not returned for evaluation, the root cause could not be established.The screw was left in situ and the head was disposed of.

• Brand Name: 2.7MM X 12MM NON-LOCKING HEXALOBE 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: 23287511
• Report Number: 3025141-2025-00565
• Device Sequence Number: 5559506
• Product Code: HWC
• UDI-Device Identifier: 10806378018312
• UDI-Public: 10806378018312
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K122538
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/13/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 30-0345-S
• Device Catalogue Number: 30-0345-S
• Device Lot Number: 604818
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2025
• Initial Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/17/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown