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

Model Number	80-4151
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned driver was visually inspected to confirm failure.Under magnification, the t8 cannulated hexalobe driver (pn 80-4151) and batch was confirmed.The driver shows signs of torsional fracture patterns, identified at the transition from the shaft to the hexalobe tip at a steep angle.A torsional fracture pattern likely indicates an excessive twisting load about the driver's central axis.Additionally, there was some visible dullness, denting and deformation on the exposed fractured edges of the hexalobe.The length was measured using mitutoyo calipers to approximate the location of fracture.The driver measured 3.437", indicating that approximately.063" broke off the driver tip.Driver tip breakage may occur when excessive force is applied to the driver during use to overcome increased resistance.This increased resistance can have many contributing factors such as encountering dense bone, inadequate pilot hole depth, and improper surgical technique.No definitive conclusion can be made.
Event or Problem Description
It was reported that during a surgical procedure, a drill tip broke during final tightening.No part of drill bit was left in the patient.

• 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: kimberly banning ; 5885 ne cornelius pass road; hillsboro, OR 97124
• MDR Report Key: 23392353
• Report Number: 3025141-2025-00557
• Device Sequence Number: 10052693
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/27/2025

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 Catalogue Number: 80-4151
• Device Lot Number: 658461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2025
• Initial Report FDA Received Date: 10/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2025
• 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
• Patient Sex: Unknown