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

Model Number 87011

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/24/2024

Event Type  Injury  

Event Description

It was reported that the tip of the driver broke off in a screw during a spinal surgery.The tip remains in the patient.There is no report of symptoms.There is no report of plans for revision surgery.

Manufacturer Narrative

The device has not returned for investigation.Photographs were provided which confirm the event.Review of the device history record indicates there were no issues during the manufacture of this product that would contribute to this complaint condition.If the device and/or additional information is received, a supplemental report will be filed accordingly.

• Brand Name: ARSENAL
• Type of Device: 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: 18898988
• MDR Text Key: 337600738
• Report Number: 2027467-2024-00015
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 00844856069565
• UDI-Public: (01)00844856069565(10)00844856069565
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 87011
• Device Catalogue Number: 87011
• Device Lot Number: MC4163603A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/15/2024
• Initial Date FDA Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/07/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Male