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

Model Number	3070-27016
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	03/09/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No product has been received to date for examination.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 report numbers (including this report): 3025141-2026-00221, 3025141-2026-00222.
Event or Problem Description
It was reported: 3 of the 2.7mm nl screws from the aculoc next set broke when drilling in the proximal oblong for the longer of the new next wrist spanning plates.Patient was 40-year-old male.Good diaphyseal bone.We are wondering if there needs to be a different larger drill or a tap available for diaphyseal bone.The screws did not break right below the screw head; it was a few threads down.Basically, whenever the bone started giving some resistance they snapped, but it was fellow with the surgeon and he was very controlled and wasn't over torquing.Screws should not have behaved like that even with some resistance.It was very odd.We left two in the oblong with the heads sheared off and a third in a screw hole distal i believe.We had two screws proximal that we locked around those.

• 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: 24758788
• Report Number: 3025141-2026-00223
• Device Sequence Number: 18336000
• Product Code: HWC
• UDI-Device Identifier: 10806378126079
• UDI-Public: 10806378126079
• Combination Product (Y/N): N
• 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): 04/01/2026

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 04/01/2026
• 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 Age: 40 YR
• Patient Sex: Male