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

Model Number	17110
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the tip of the screwdriver sheared off during use.There were no fragments left in the patient.There were no patient symptoms or complications reported as result of this event.
Additional Manufacturer Narrative
The screwdriver returned for evaluation.Visual inspection found a clean shear fracture of the distal tip.The failure appears to be the result of torsion, which is consistent with its designed use.The screwdrivers are used in conjunction with ratcheting axial or t handles for screw insertion.It is likely excessive torque was applied to the device during use.Review of the device history record indicates the instrument conformed to dimensional specifications at the time of manufacturing and passed inspection requirements with no non-conformities reported.
Additional Manufacturer Narrative
Udi related data quality updates only.Corrected information: d4.Serial #: blank.Lot #: cmn36250.

• Brand Name: INVICTUS
• 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: 17896554
• Report Number: 2027467-2023-00067
• Device Sequence Number: 3366601
• Product Code: HXX
• UDI-Device Identifier: 00190376192680
• UDI-Public: (01)00190376192680(10)CMN36250
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2023

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/09/2023
• Supplement Report FDA Received Date: 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2022
• 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: 71 YR
• Patient Sex: Male