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 Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No product has been received to date so an examination cannot be performed.No definitive conclusion can be made.If any additional information becomes available, a follow up submission will be sent.Related mdr: 3025141-2026-00270.
Event or Problem Description
It was reported: 2 2.7mm nl screws from al next broke during the case.The first screw (16mm) broke while the screw was being used to pull the plate to the bone.The head of the screw broke in half and then fell through the slot in the plate.The second screw head snapped off the screw before it was even down to the plate.

• 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 ; 3885 arapaho rd; addison, TX 75001
• MDR Report Key: 25104615
• Report Number: 3025141-2026-00271
• Device Sequence Number: 10744859
• Product Code: HWC
• UDI-Device Identifier: 10806378126079
• UDI-Public: 10806378126079
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K251132
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted 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): 05/06/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 3070-27016
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2026
• Initial Report FDA Received Date: 05/06/2026
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Race: White