MAUDE Adverse Event Report: ACUMED, LLC 20MM, 3.5 MINI ACUTRAK 3® BONE SCREW; SCREW, FIXATION, BONE

Model Number	3052-35020
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/19/2025
Type of Reportable Event	Malfunction
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 notify acumed with the information directly after the case concluded.Related reports (including this one): 3025141-2026-00291, 3025141-2026-00292.
Event or Problem Description
The acumed sales representative reported, "the doctor did a scaphoid, broke 2 driver tips, broke and shattered the tip about half way down.The procedure was completed by fishing pieces out, easy out, screw left slightly prominent.There was a 45 minute delay due to the malfunctions and the patient remained stable.".

• Brand Name: 20MM, 3.5 MINI ACUTRAK 3® BONE 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: 25194181
• Report Number: 3025141-2026-00293
• Device Sequence Number: 8963328
• Product Code: HWC
• UDI-Device Identifier: 10806378120909
• UDI-Public: 10806378120909
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K230744
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 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: 3052-35020
• Device Lot Number: NOT REPORTED
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2025
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown