MAUDE Adverse Event Report: ACUMED LLC 2.7MM X 16MM NL HEXALOBE SCREW; SCREW, FIXATION, BONE

Model Number	3070-27016
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product has been received to date so an examination cannot be performed.Additional reporting on this event will be provided as a follow up report if more information becomes available.Related reports including this one: 3025141-2026-00183, 3025141-2026-00185.3025141-2026-00186, 3025141-2026-00187.
Event or Problem Description
It was reported: bilateral distal radius fractures that extend into the proximal radius.Pt.Is a rather large male.We used a wide right plate with the medium extension plate and a standard long left plate with the neutral extension.In both the left and right, as dr.(b)(6) was finishing is proximal fixation, he was fully seating his screws and the screws broke.They broke right at the neck of the screw where the head and body meet.He did not use an excessive amount of torque as he was fully seating these screws.I believe he broke the 2.7 x 16 in the right radius and 2.7 x 14 in the left radius but i'm not 100% on that.

• Brand Name: 2.7MM X 16MM NL 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: aram tran ; 5885 ne cornelius pass road; hillsboro, OR 97124
• MDR Report Key: 24599071
• Report Number: 3025141-2026-00184
• Device Sequence Number: 13136580
• Product Code: HWC
• UDI-Device Identifier: 10806378125478
• UDI-Public: 10806378125478
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: K251132
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/13/2026

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: 3070-27016
• Device Catalogue Number: 3070-27016
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 03/13/2026
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 53 YR
• Patient Sex: Male