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

Model Number	17110;17110
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The devices were returned to alphatec for evaluation.Visual inspection confirms a shear fracture of the distal hexalobe tip on both devices.Based on the information available, it appears the root cause is likely a result of excessive torque applied to the device during use.A review of the device history records did not identify any manufacturing or processing-related irregularities that could have contributed to the issue reported.They were found to be properly manufactured and released in accordance with design specifications.
Event or Problem Description
It was reported the tip of two screwdrivers sheared off while trying to change the trajectory of a polyaxial screw implanted in cortical bone.The tip of the first driver was retrieved.The tip of the 2nd driver remains in the polyaxial screw which was successfully removed from the patient.There was no impact to the patient nor a delay in surgery as a result of this event.

• Brand Name: INVICTUS SPINAL FIXATION SYSTEM
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): ALPHATEC SPINE, INC.; 1950 camino vide 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: 16453531
• Report Number: 2027467-2023-00013
• Device Sequence Number: 14920909
• Product Code: HXX
• UDI-Device Identifier: 00190376192680
• UDI-Public: (01)00190376192680
• 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): 02/24/2023

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;17110
• Device Catalogue Number: 17110;17110
• Device Lot Number: TI00029;AV00548
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2023
• Initial Report FDA Received Date: 02/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 59 YR
• Patient Sex: Male