MAUDE Adverse Event Report: ALPHATEC SPINE, INC ARCUS GUIDED ACCESS SYSTEM - DIAMOND TIP, STERILE; NEUROSURGICAL NERVE LOCATOR

Model Number	16122-01-S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not returned.If any additional information is provided, a supplemental report will be submitted.
Event or Problem Description
After insertion in the pedicle, the plastic handle became loose on the cannula and could not be used to spin and pull out.This caused a delay in surgery.No patient injury reported.

• Brand Name: ARCUS GUIDED ACCESS SYSTEM - DIAMOND TIP, STERILE
• Common Device Name: NEUROSURGICAL NERVE LOCATOR
• Manufacturer (Section D): ALPHATEC SPINE, INC; 1950 camino vida roble; carlsbad CA 92008
• MDR Report Key: 12304958
• Report Number: 2027467-2021-00060
• Device Sequence Number: 3974019
• Product Code: PDQ
• UDI-Device Identifier: 00190376240268
• UDI-Public: 00190376240268
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K191723
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/12/2021

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: No Information
• Device Model Number: 16122-01-S
• Device Catalogue Number: 16122-01-S
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR