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

Model Number	17110
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was used for treatment, not diagnosis.Information regarding the patient's bone quality or medical history was not provided.An evaluation of the returned polyaxial screwdriver found that the distal tip had fractured and became separated from the instrument.The fractured tip was not returned.A previous investigation conducted for this type of occurrence determined that this is likely the result of implantation in hard dense bone, which required an increased torsional load that exceeded the design limits of the instrument.If additional information is provided, a supplemental report will be issued.
Event or Problem Description
It was reported while trying to remove previously implanted hardware due to a non-union of the fusion, the tip of the screwdriver broke off.The tip was retrieved.This did not cause a delay in surgery.There were no patient symptoms or complications reported as a result of this event.

• Brand Name: INVICTUS SPINAL FIXATION SYSTEM
• 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: 16273777
• Report Number: 2027467-2023-00001
• Device Sequence Number: 12282622
• Product Code: HXX
• UDI-Device Identifier: 00190376192680
• UDI-Public: (01)00190376192680(10)TI00029
• 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): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/30/2023

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: 17110
• Device Catalogue Number: 17110
• Device Lot Number: TI00029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2023
• Initial Report FDA Received Date: 01/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/20/2021
• 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 Age: 68 YR
• Patient Sex: Male