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

Model Number	80-4244
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A visual examination under magnification of the returned parts was performed.The batch number of the t8 stick fit hexalobe driver was identified as 687124.The tip exhibit a torsional, oblique fast fracture, which occurred after the rounded portion of the tip.A torsional fracture pattern likely indicates an excessive twisting load about the driver's central axis while an oblique fracture pattern indicates excessing loading off the central axis to the driver.Hexalobe 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 reorted that the driver broke during use.The procedure was completed using another driver.There was no reported delay or adverse consequence to the patient.

• 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: 24351742
• Report Number: 3025141-2026-00110
• Device Sequence Number: 16002515
• Product Code: LXH
• UDI-Device Identifier: 10806378126598
• UDI-Public: 10806378126598
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/16/2026

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: 80-4244
• Device Catalogue Number: 80-4244
• Device Lot Number: 687124
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2026
• Initial Report FDA Received Date: 02/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Age: 60 YR
• Patient Sex: Female