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

Model Number	17908
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the tip of the driver broke off during surgery.The tip was retrieved and discarded at the hospital.There were no patient symptoms or complications reported as result of this event.
Additional Manufacturer Narrative
The device did not return for evaluation.The identifying lot number was not provided; therefore, a review of the device history record could not be conducted.Based on the information provided, the root cause could not be determined.
Additional Manufacturer Narrative
D4.Lot# av00822 d9.Yes h3, yes h4.(b)(6)2023 h6.Investigation findings: 3251 investigation conclusion: 61 h10.Visual inspection of the device found the distal tip had fractured and became separated from the instrument.Inspection under magnification revealed circular fracture lines indicative of a torsional overload.The invictus spinal fixation system is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine.The instruments in this system are intended for use in surgical procedures.Possible adverse effects: the following complications and adverse reactions have been shown to occur with the use of similar spinal instrumentation.These effects and any other known by the surgeon must be discussed with the patient preoperatively.1.Initial or delayed loosening, disassembly, bending, dislocation, and/or breakage of device components.
Additional Manufacturer Narrative
Corrected information: d4.Udi #: (b)(4).

• 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: 18020971
• Report Number: 2027467-2023-00071
• Device Sequence Number: 6585750
• Product Code: HXX
• UDI-Device Identifier: 00190376419145
• UDI-Public: (01)00190376419145
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 10/26/2023

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: 17908
• Device Catalogue Number: 17908
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2023
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 10/27/2023
• Supplement Report FDA Received Date: 04/24/2024; 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown