MAUDE Adverse Event Report: ACUMED, LLC T8 STICK FIT HEXALOBE DRIVER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	80-0759
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Type of Reportable Event	Serious Injury
Event or Problem Description
The following was reported: "royal devon and exeter have reported a t8 screwdriver snapping during a case.I spoke to the surgeon who did it and she said she didn't put any extra force to cause it to break.Unfortunately, where it snapped, part of the screwdriver was left in the screw head.They had to leave this in the patient as i they could not remove it at the time.
Additional Manufacturer Narrative
To date, the device has not returned for evaluation as it was reported as discarded.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.

• Brand Name: T8 STICK FIT HEXALOBE DRIVER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 24732951
• Report Number: 3025141-2026-00256
• Device Sequence Number: 16018669
• Product Code: LXH
• UDI-Device Identifier: 10806378044540
• UDI-Public: 10806378044540
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K233311
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/30/2026

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: 80-0759
• Device Lot Number: NOT REPORTED
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 03/30/2026
• 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