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

Model Number	17950-225
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of the driver broke off when inserting the screw into the ilium.All broken pieces were removed from the patient.No further complications were reported.This is report 2 of 2.
Additional Manufacturer Narrative
The device is currently being evaluated.A follow-up report with the results of the investigation will be submitted upon completion.
Additional Manufacturer Narrative
This is report 2 of 2.Corrected information: h3.Yes, h6.Investigation findings: 3252, investigation conclusion: 61.Device evaluation: visual inspection confirms that the distal tip has sheared off at the base of the hexalobe.This failure is likely due to the applied torsional force being greater than the yield strength.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.

• Brand Name: INVICTUS
• 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: 20613048
• Report Number: 2027467-2024-00141
• Device Sequence Number: 8874412
• Product Code: HXX
• UDI-Device Identifier: 00190376473017
• UDI-Public: (01)00190376473017(10)EM53910
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2024

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: 17950-225
• Device Catalogue Number: 17950-225
• Device Lot Number: EM53910
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/05/2024
• Supplement Report FDA Received Date: 11/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/29/2024
• 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