MAUDE Adverse Event Report: ALPHATEC SPINE, INC. INVICTUS; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	17140
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual inspection confirms the event.The t25 amoeba drive tip at the distal end of the instrument is twisted in a clockwise direction and a majority of the hexalobe has sheared off from the driver.The break of the driver tip suggests combined shear and torsional failure.Shear failure is characteristic of cantilever bending at the distal end of the t25 driver tip, which is more likely to occur due to eccentric loading and/or the driver tip not being fully seated into the female hex during use.Review of device history records showed no manufacturing or processing related irregularities that would cause or contribue to this failure mode.Labeling review: warnings/cautions/precautions: 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 that the tip of the driver broke off when inserting a screw.The tip was removed from the patient.No further complications were reported as a result of the event.

• Brand Name: INVICTUS
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• 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: 20740916
• Report Number: 2027467-2024-00156
• Device Sequence Number: 8287565
• Product Code: OLO
• UDI-Device Identifier: 00190376195902
• UDI-Public: (01)00190376195902(10)EM52316
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K153603
• 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): 11/20/2024

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: 17140
• Device Catalogue Number: 17140
• Device Lot Number: EM52316
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2024
• Initial Report FDA Received Date: 11/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2023
• 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