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

Model Number	17138
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation of the returned driver found that the distal tip had fractured and became separated from the instrument.The invictus driver pn 17138 is used to final tighten set screws up-to 110 in lb with use of the invictus torque limiting handle pn 17093-110.The driver is manufactured from material ss 465 h900.Visual investigation revealed that the failure is shear of the hexalobe.This failure occurs when the applied force on the instrument exceeds the instrument strength.Per an internal test report, the ultimate torque for the t-27 hexalobe is documented as 180.58 +/-0.85 in-lb; which is 1.6 safety factor to the 110-tightening torque.Therefore, it is noted that the failure was not a result of a tightening torque with a torque limiting handle.Shear failure occurred due to an excessively high torque being applied during use, likely combined with bending loads.Investigation of lot# 8624605 indicated the material and manufacturing are within design specifications.
Event or Problem Description
During surgery, the hexalobe tip sheared off.The surgeon used suction to remove it from the screw.

• 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: 15505931
• Report Number: 2027467-2022-00067
• Device Sequence Number: 5224570
• Product Code: HXX
• UDI-Device Identifier: 00190376185811
• UDI-Public: (01)00190376185811(10)8624605
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 08/29/2022

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: 17138
• Device Catalogue Number: 17138
• Device Lot Number: 8624605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2022
• Initial Report FDA Received Date: 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2020
• 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: Female