MAUDE Adverse Event Report: ACUMED, LLC 2.7MM X 14MM NL HEXALOBE SCREW; SCREW, FIXATION, BONE

Model Number	3070-27014
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	01/05/2026
Type of Reportable Event	Serious Injury
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 reports (including this one): 3025141-2026-00103.
Event or Problem Description
It was reported that a 2.7 x 14 mm non-locking screw was placed into the oblong hole of the distal radius plate.While taking final x rays we noticed that the screw was too long and needed to be replaced.When the resident went to remove the screw, the head of the screw snapped off.The screw was left in the bone, and the screw was cut from the dorsal end so it was flush with bone.There were 30 minute delay and additional incision required.

• Brand Name: 2.7MM X 14MM 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: kimberly banning ; 5885 ne cornelius pass road; hillsboro, OR 97124
• MDR Report Key: 24195770
• Report Number: 3025141-2026-00066
• Device Sequence Number: 9766612
• Product Code: HWC
• UDI-Device Identifier: 10806378126055
• UDI-Public: 10806378126055
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K251132
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• 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): 01/27/2026

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: 3070-27014
• Device Catalogue Number: 3070-27014
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2026
• Initial Report FDA Received Date: 01/27/2026
• 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: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White