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

Model Number	17137
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual inspection confirms that the distal t-27 hexalobe tip of the final driver has completely sheared off.The tip was not returned with the instrument.The root cause is likely due to the applied force on the instrument exceeding the design strength of the instrument.Review of device history records showed no manufacturing or processing related irregularities.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 sheared off during a case.The tip was retrieved from the patient.
Additional Manufacturer Narrative
Corrected information: d4.Model #: 17138.

• Brand Name: INVICTUS 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: 21427814
• Report Number: 2027467-2025-00019
• Device Sequence Number: 7913475
• Product Code: HXX
• UDI-Device Identifier: 00190376185811
• UDI-Public: (01)00190376185811(10)8698515
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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,Followup
• Report Date (Section B): 02/20/2025

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: 17137
• Device Catalogue Number: 17138
• Device Lot Number: 8698515
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/20/2025
• Supplement Report FDA Received Date: 02/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2021
• 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