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

Model Number	16021
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is currently being evaluated.A follow-up report with the results of the investigation will be submitted upon completion.
Event or Problem Description
It was reported that the tip of the inserter sheared off.No pieces were left in the patient.There is not report of patient symptoms or complications reported as a result.
Additional Manufacturer Narrative
Corrected information: h3.Yes.Investigation findings: 3243.Investigation conclusions: 18, 61.H10.The universal cross connector inserter returned with the tip sheared off.The profile of the hexalobe tip has a twist consistent with deformation seen from applying too much torque in a counterclockwise motion.The universal cross connector inserter is interned to be used for insertion and provisional tightening of the set screw of the universal cross connector.The set screw should be provisionally tightened and then final tightened with a universal cross connector final driver and 40-inch pound torque limiting handle.Deformation and shearing of the hexalobe is consistent with the universal cross connector inserter being used to loosen a final tightened set screw.It is likely the user applied more torque than the instructed torque of 40-inch pounds as testing has shown the universal cross connector inserter can handle a reverse torque of ~70-inch pounds before shearing.Review of device history records indicates that there were no manufacturing or processing-related irregularities.They were found to be properly manufactured and released in accordance with design specifications.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.Preoperative management: surgeons should have a complete understanding of the surgical technique, system indications, contraindications, warnings and precautions, safety information, as well as functions and limitations of the implants and instruments.Intraoperative management: final tightening of set screws: all set screws must be tightened using the appropriate instruments (e.G., torque handle, final driver, and counter torque) as indicated in the surgical technique guide.

• Brand Name: INVICTUS
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL 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: 18842320
• Report Number: 2027467-2024-00003
• Device Sequence Number: 15257918
• Product Code: LXH
• UDI-Device Identifier: 00190376284637
• UDI-Public: (01)00190376284637(10)8693301
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 03/05/2024

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: 16021
• Device Catalogue Number: 16021
• Device Lot Number: 8693301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2024
• Supplement Date Received by Manufacturer: 02/05/2024
• Initial Report FDA Received Date: 03/05/2024
• Supplement Report FDA Received Date: 03/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/22/2021
• 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