MAUDE Adverse Event Report: ACUMED LLC 2.7MM X 15MM NL HEXALOBE SCREW; SCREW, FIXATION, BONE

Model Number	3070-27015
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	01/12/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the screw broke in the distal end of the slot in the wrist spanning plate.It sheared off right at the bone surface with about one thread left under the head of the screw.The surgeon mentioned it was dense bone and he left the broken screw in the bone and mentioned that he would remove it using a trephine when he removes the wsp.He mentioned that he wasn't too concerned about the removal because the bone quality was very good and the patient is young.He was able to insert a second nl screw into the proximal portion of the same slot, so the breakage didn't affect his fixation.
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.

• Brand Name: 2.7MM X 15MM NL HEXALOBE 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: 24328622
• Report Number: 3025141-2026-00082
• Device Sequence Number: 9674828
• Product Code: HWC
• UDI-Device Identifier: 10806378126062
• UDI-Public: 10806378126062
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K251132
• 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): 02/11/2026

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: 3070-27015
• Device Catalogue Number: 3070-27015
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2026
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 25 YR
• Patient Sex: Male
• Patient Race: Asian