MAUDE Adverse Event Report: ACUMED, LLC 36MM, 2.0 NANO ACUTRAK 3® BONE SCREW; DRIVER, PROSTHESIS

Model Number	3050-20036
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a dip fusion procedure, the surgeon had a 36 mm nano acutrak 3 screw lose structural integrity.While inserting the screw, the distal dip where the cutting threads/flutes are, mushroomed out and welded to the wire.The screw stopped its insertion and was stuck.The surgeon was able to remove the screw and wire combo without breaking either.He replaced the wire and put in another nano acutrak 3 with no issue to complete the procedure.There was a 15-29 minute delay reported.
Additional Manufacturer Narrative
One 3050-20036 36 mm, 2.0 nano acutrak 3 bone screw (no batch number provided or visible) and one guide wire (no part number, batch number or part name visible) were returned and examined under magnification.Upon initial examination, the guide wire presents as bent on both sides of the welded screw.It is unclear whether this occurred at the time of the incident, during removal, or during transport.Under magnification, the end of the screw that has deformed appears to bend outward along the circumference of the screw tip, splitting along the screw flutes.It is possible that the bent guide wire and/or biological material buildup contributed to the screw having difficulty inserting.Additionally, improper drilling depth or encountering dense bone could have contributed to the damage observed to the screw.It is also possible that the guide wire was bent upon insertion due to off-axis loading.Upon attempt, the screw was unable to be removed from the wire.No definitive conclusion can be made.

• Brand Name: 36MM, 2.0 NANO ACUTRAK 3® BONE SCREW
• Common Device Name: DRIVER, PROSTHESIS
• 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: 25782473
• Report Number: 3025141-2026-00350
• Device Sequence Number: 18548211
• Product Code: HWC
• UDI-Device Identifier: 10806378120589
• UDI-Public: 10806378120589
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K230744
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 07/09/2026

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: 3050-20036
• Device Lot Number: NOT REPORTED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2026
• Initial Report FDA Received Date: 07/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE WIRE
• Outcome Attributed to Adverse Event: Other
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Race: White