MAUDE Adverse Event Report: ACUMED, LLC ARC WRIST TOWER UPPER ARC; APPARATUS, TRACTION, NON-POWERED

Model Number	10100015
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2026
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.Additional reporting on this event will be provided as a follow up report if more information becomes available.Related reports (including this report): 3025141-2026-00107, 3025141-2026-00108, 3025141-2026-00109.
Event or Problem Description
It was reported that while cross threading on 2 separate arc wrist towers, the tower arm and tension knob got stuck and would not move.The procedure was completed using another arc wrist tower.A reported delay of 20 minutes with no adverse consequences to the patient.

• Brand Name: ARC WRIST TOWER UPPER ARC
• Common Device Name: APPARATUS, TRACTION, NON-POWERED
• 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: 24351647
• Report Number: 3025141-2026-00106
• Device Sequence Number: 14642400
• Product Code: HST
• UDI-Device Identifier: 10806378010095
• UDI-Public: 10806378010095
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/16/2026

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: 10100015
• Device Catalogue Number: 10100015
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2026
• Initial Report FDA Received Date: 02/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• 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