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

Model Number	17026
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The distal tip of the driver shaft sheared off during final tightening.No patient injury reported.
Additional Manufacturer Narrative
The returned device is currently being evaluated.A follow up report with results of the investigation will be submitted upon completion.
Additional Manufacturer Narrative
Corrective data: h6: medical device problem code: 1069.Additional information: h6: component code: 4756.Investigation findings: 3252.H10: a review of the device history record did not identify any manufacturing or processing related irregularities.Visual inspection the distal hexalobe tip sheared from the driver shaft.No observable damage besides cosmetic scratches were found on the remainder of the instrument.The most likely failure mode of the final driver, stop is wear and tear over time.The driver has been in the field since (b)(6) 2019.The instrument likely reached its fatigue limit during the application of requisite torque (90 in-lb) during the cause, causing the tip to shear.

• 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 roble vida; carlsbad, CA 92008 ; 9014283693
• MDR Report Key: 13481120
• Report Number: 2027467-2022-00003
• Device Sequence Number: 5147497
• Product Code: HXX
• UDI-Device Identifier: 00190376234175
• UDI-Public: 00190376234175
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 01/11/2022

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: 17026
• Device Catalogue Number: 17026
• Device Lot Number: 8407013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2022
• Supplement Date Received by Manufacturer: 01/11/2022
• Initial Report FDA Received Date: 02/08/2022
• Supplement Report FDA Received Date: 03/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/25/2019
• 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: 83 YR
• Patient Sex: Male