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

Model Number 17950-225

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/16/2024

Event Type  Injury  

Manufacturer Narrative

The device is currently being evaluated.A follow-up report with the results of the investigation will be submitted upon completion.

Event Description

The tip of the driver broke off into a screw shank during a case.The screw and driver tip remain in the patient.There was no report of patient symptoms or complications due to this event.

Manufacturer Narrative

Corrected information: h3.Yes.Investigation findings: 3252.Investigation conclusion: 61.Additional information: visual inspection confirms the distal tip of the driver sheared off.The failure is likely due to the applied torsional force being greater than the yield strength of the tip.Review of device history records showed there were no manufacturing or processing related irregularities.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
• Type of Device: 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: 18695625
• MDR Text Key: 335254858
• Report Number: 2027467-2024-00006
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 00190376473017
• UDI-Public: (01)00190376473017(10)EM49771
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Followup
• Report Date: 02/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 17950-225
• Device Catalogue Number: 17950-225
• Device Lot Number: EM49771
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/13/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/06/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/17/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1