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

Model Number	17026
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device did not return for investigation.Photographs were not provided; therefore, the complaint cannot be confirmed.The lot number was not provided; therefore, a review of device history records cannot be performed.Based on the information provided the root cause cannot be determined.Multiple attempts have been made to obtain the device.If additional information and/or the device are provided, a supplemental report will be filled accordingly.
Event or Problem Description
It was reported that the tip of the driver broke off during a case.The tip was retrieved from the patient.

• 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: 19624524
• Report Number: 2027467-2024-00069
• Device Sequence Number: 12332809
• Product Code: HXX
• UDI-Device Identifier: 00190376234175
• UDI-Public: (01)00190376234175
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/26/2024

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: 17026
• Device Catalogue Number: 17026
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2024
• Initial Report FDA Received Date: 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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