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

Model Number	87134
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the tip of the driver broke while removing hardware during a revision surgery.The tip was retrieved.
Additional Manufacturer Narrative
The device is currently being evaluated.A supplemental report will be submitted once the investigation is complete.
Additional Manufacturer Narrative
Corrected information: h3.Yes.H6.Type of investigation: 10, 3331.Investigation findings: 3252.Investigation conclusion: 61.Additional information: visual inspection confirms the hexalobe drive feature sheared off.This failure is due to unintended use of the device.This driver is meant to drive set screws with expected torque values.This driver was used to remove hardware which is the opposite direction of expected loads and can result in forces greater than those in which the instrument is designed for.Review of device history records showed there were no manufacturing or processing related irregularities.Labelling review: "when adequate distraction is attained, use the t27 set screw driver to tighten the set screw and maintain distraction".Warnings: 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.

• 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: 19234845
• Report Number: 2027467-2024-00043
• Device Sequence Number: 20297434
• Product Code: HXX
• UDI-Device Identifier: 00840967197906
• UDI-Public: (01)00840967197906(10)7897401
• 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): 05/02/2024

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: 87134
• Device Catalogue Number: 87134
• Device Lot Number: 7897401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/02/2024
• Supplement Report FDA Received Date: 05/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/21/2017
• 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