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

Model Number	87011
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned and evaluated.Visual inspection confirms the tip has sheared off.The broken tip was not returned with the rest of the device.Shear failure of the hexalobe occurs when the applied force of the instrument exceeds the design strength.There were no manufacturing or processing-related irregularities.They were found to be properly manufactured and released in accordance with design specifications.Warnings/cautions/precautions: risks identified with the use of these devices, which may require additional surgery, include device component failure, loss of fixation/stabilization, non-union, vertebral fracture, neurological injury, vascular or visceral injury.Possible adverse effects: initial or delayed loosening, disassembly, bending, dislocation and/or breakage of device components.
Event or Problem Description
It was reported that the tip of the driver broke off in a screw during a spinal surgery.The screw and driver tip were removed from the patient, and a new screw was placed.There were no complications or symptoms due to this event.

• Brand Name: ARSENAL
• 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: 19038483
• Report Number: 2027467-2024-00035
• Device Sequence Number: 7354951
• Product Code: HXX
• UDI-Device Identifier: 00844856069565
• UDI-Public: (01)00844856069565(10)MC4070501CR
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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): 04/03/2024

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: 87011
• Device Catalogue Number: 87011
• Device Lot Number: MC4070501CR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/21/2021
• 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: 74 YR
• Patient Sex: Male