MAUDE Adverse Event Report: ALPHATEC SPINE, INC. ARSENAL SPINAL FIXATION SYSTEM; SCREWDRIVER

Model Number	87134
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual inspection confirms that the tip of the driver is fractured.This failure is due to unintended use of the device.The driver is meant to drive set screws with expected torque values.This driver was used to remove hardware which is the opposite direction of expected loads and can result in forces greater than those in which the instrument is designed for.Review of device history records showed no manufacturing or processing related irregularities.Labeling review: "when adequate distraction is attained, use the t27 set screw driver to tighten the set screw and maintain distraction." warnings: risks identified with the use of these devices, which may require additional surgery, include device component failure, loss of fixation/stabilization, non-union, vertebral fracture, neurological injury, vascular or visceral injury.Possible adverse effects: initial or delayed loosening, disassembly, bending, dislocation and/or breakage of device components.
Event or Problem Description
It was reported the tip of the driver broke off while trying to remove previously implanted hardware.The tip was recovered and disposed of at the hospital.

• Brand Name: ARSENAL SPINAL FIXATION SYSTEM
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): ALPHATEC SPINE, INC.; 1950 camino vida roble; carlsbad CA 92008
• Manufacturer (Section G): ALPHATEC SPINE, INC.; 1950 camino vida roble; carlsbad CA 92008
• Manufacturer Contact: wesley channell ; 1950 camino vida roble; carlsbad, CA 92008 ; 9014283693
• MDR Report Key: 21596936
• Report Number: 2027467-2025-00033
• Device Sequence Number: 9079955
• Product Code: HXX
• UDI-Device Identifier: 00840967197906
• UDI-Public: (01)00840967197906(10)8373901
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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): 03/13/2025

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: 87134
• Device Catalogue Number: 87134
• Device Lot Number: 8373901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2025
• Initial Report FDA Received Date: 03/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2017
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown