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	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a case, two screwdrivers broke and the ratcheting handle was not functioning appropriately.The facility ended up disposing the 2 broken screw drivers.
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.Related reports (including this one) 3025141-2026-00309, 3025141-2026-00310.

• 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 ; 5885 ne cornelius pass road; hillsboro, OR 97124
• MDR Report Key: 25463744
• Report Number: 3025141-2026-00310
• Device Sequence Number: 18725964
• Product Code: HWR
• UDI-Device Identifier: 10806378121623
• UDI-Public: 10806378121623
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/10/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 80-4151
• Device Lot Number: NOT REPORTED
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2026
• Initial Report FDA Received Date: 06/10/2026
• 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
• Patient Sex: Unknown