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

Model Number	17111
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
While trying to remove a screw, the tip of the driver broke off and the tower of the screw popped.The surgery was successfully completed.
Additional Manufacturer Narrative
The device is currently being evaluated.A follow-up report with the results of the investigation will be submitted upon completion.
Additional Manufacturer Narrative
H3.Yes.H6: component code: 4756.Investigation findings: 3252.Investigation conclusion: 61.H10: a review of the device history records did not identify any manufacturing or processing-related irregularities related to the hex tip geometry, cannulation size, or other physical features related to the distal working end.Distal hex is confirmed sheared off and missing.The screwdriver locking thumbwheel actuates properly and the threaded sleeve translates along the inner shaft smoothly and freely.Besides damage to the distal hex there are no other signs of heavy wear or misuse.The size of the screw or patient bone quality is not stated in the complaint.The root cause is a result of the screwdriver input torque exceeded the design strength of the driver tip.

• Brand Name: INVICTUS
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): 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: 14382293
• Report Number: 2027467-2022-00029
• Device Sequence Number: 4991110
• Product Code: HXX
• UDI-Device Identifier: 00190376192710
• UDI-Public: (01)00190376192710(10)TI00030
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• 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
• Report Date (Section B): 04/12/2022

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
• Device Model Number: 17111
• Device Catalogue Number: 17111
• Device Lot Number: TI00030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2022
• Supplement Date Received by Manufacturer: 04/12/2022
• Initial Report FDA Received Date: 05/12/2022
• Supplement Report FDA Received Date: 06/18/2022
• 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