MAUDE Adverse Event Report: ACUMED, LLC 2.7MM X 18MM NON-LOCKING HEXALOBE SCREW; SCREW, FIXATION, BONE

Model Number	30-0348
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/27/2026
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.Acumed post market surveillance did confirm the reported incident with the acumed representative who was present at the surgery.The acumed representative did notifiy acumed with the information directly after the case concluded.Related reports (including this one): 3025141-2026-00296 (mw5186891) and (mw5186892).
Event or Problem Description
Mw5186891 was received by acumed on april 17, 2026 with the following reported, "during surgical open reduction internal fixation acumed screws x 2 broke when implanted into right acumed plate.Remnants left in right ulna per surgeon discretion.Screws 30-0348 2.7mm x 18mm and 30-0328 2.7mm x 16mm.Hecc: 2687.Dpc: 1261, 1212.Ref: mw5186892.".

• Brand Name: 2.7MM X 18MM NON-LOCKING 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: 25194475
• Report Number: 3025141-2026-00297
• Device Sequence Number: 21476294
• Product Code: HWC
• UDI-Device Identifier: 10806378018367
• UDI-Public: 10806378018367
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K120903
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/15/2026

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: 30-0348
• Device Lot Number: NOT REPORTED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 05/15/2026
• 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: 35 YR
• Patient Sex: Male
• Patient Weight: 49 KG
• Patient Race: White