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	04/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
While over torquing was indicated in the complaint report.No product has been returned to date so an examination cannot be performed.If any additional information is obtained a follow up report will be submitted.
Event or Problem Description
It was reported: " a driver tip broke during a case.Doctor had explained to the rep he may have over torqued the screw due to the screw head not seating in plate.".

• 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 ; 3885 arapaho rd; addison, TX 75001
• MDR Report Key: 25249876
• Report Number: 3025141-2026-00279
• Device Sequence Number: 21466149
• Product Code: LXH
• UDI-Device Identifier: 10806378126598
• UDI-Public: 10806378126598
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/21/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 80-4244
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2026
• Initial Report FDA Received Date: 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/22/2026
• 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 Sex: Unknown