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	09/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The driver has not returned for evaluation.Photographs were not provided.A review of the device history records could not be performed as the identifying lot number was not provided.The root cause is unintended use of the device.The 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.Alphatec spine is submitting this report to comply with the fda regulations 21 cfr 803.Alphatec spine has made reasonable efforts to provide as much relevant information as available.Any field that is left blank was not known at the time of this submission.If additional information is provided, a supplemental report will be submitted.
Event or Problem Description
It was reported that the driver broke during removal of a screw.This is report 2 of 3.
Additional Manufacturer Narrative
Additional information: d4.Lot #: 8126801; h4.Device manufacture date: 07/16/2018.Corrected information: d4.Primary udi: (b)(4).D9.Yes, returned to manufacturer on 11/15/2024.H3.Yes.H6.Type of investigation: 10, 3331.Investigation findings: 3252.Investigation conclusions: 18, 61.Device evaluation: visual inspection confirms the hexalobe feature has sheared off.This failure is due to unintended use of the device.The driver is meant to driver 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 no manufacturing or processing related irregularities that would cause or contribute to this event.Labeling review: 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 ; 9074283693
• MDR Report Key: 20477216
• Report Number: 2027467-2024-00128
• Device Sequence Number: 20901854
• Product Code: HXX
• UDI-Device Identifier: 00840967197906
• UDI-Public: (01)00840967197906
• 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): 10/17/2024

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/17/2024
• Supplement Report FDA Received Date: 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown