MAUDE Adverse Event Report: ACUMED LLC T8 CANNULATED HEXALOBE DRIVER; DRIVER, PROSTHESIS

Model Number	80-4151
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported: case was for a scaphoid fracture.Used the acutrak 3 mini.The cannulated non stick driver tip for the mini broke at the tip during insertion.It was able to removed and didn't cause an issue.They were able to finish the case with another driver tip.15 minute delay.
Additional Manufacturer Narrative
No product has been received to date so an examination cannot be performed.If additional information becomes available, a follow up report will be submitted.

• Brand Name: T8 CANNULATED HEXALOBE DRIVER
• 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 ; 3885 arapaho rd; addison, TX 75001
• MDR Report Key: 25155830
• Report Number: 3025141-2026-00272
• Device Sequence Number: 18479557
• Product Code: HWR
• UDI-Device Identifier: 10806378121623
• UDI-Public: 10806378121623
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/12/2026

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: 80-4151
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2026
• Initial Report FDA Received Date: 05/12/2026
• 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