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

Model Number	80-4145
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
To date, the device has not returned for evaluation and has been reported to acumed that it will not be returned, 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.
Event or Problem Description
It was reported that the driver broke implanting the screw.The sales representative reported the surgical technique was followed, utilized dense bone long drill and the procedure was completed using another driver after a 15 min delay.

• Brand Name: T8 CANNULATED STICK FIT 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 ; 5885 ne cornelius pass road; hillsboro, OR 97124
• MDR Report Key: 25337516
• Report Number: 3025141-2026-00302
• Device Sequence Number: 5291661
• Product Code: HWR
• UDI-Device Identifier: 10806378121661
• UDI-Public: 10806378121661
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/29/2026

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: 80-4145
• Device Lot Number: NOT REPORTED
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 05/29/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN SCREW.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Race: White