MAUDE Adverse Event Report: ALPHATEC SPINE, INC. ARCUS STIMULATING TARGETING NEEDLE, BEVEL TIP; NEUROSURGICAL NERVE LOCATOR

Model Number	16122-02-S
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the tip of the targeting needle broke during a case and was left in the patient.
Additional Manufacturer Narrative
The device is currently being evaluated.A follow-up report with the results of the investigation will be submitted upon completion.
Additional Manufacturer Narrative
Correction: h3.Yes.H6.Investigation findings: 3252.Investigation conclusions: 61.Device evaluation: visual inspection confirms the event.The tip of the device has sheared off.Radiographic images confirm that the tip remains in the patient.The root cause of this event is likely a result of the stylet core getting bent or stuck in bone increasing the force required to remove the stylet core from the handle.Review of device history records showed no manufacturing or processing related irregularities.Labeling review: the arcus stimulating targeting needle is a single use instrument used to initiate or "target" the pedicle in conjunction with other mis instruments (e.G., k-wire or guide wire).Arcus is offered with an impaction type handle with either a diamond or bevel tip.The distal shaft and tip are made of conductive materials, so the instrument can act as a stimulation electrode.Indications: the safeop accessory instruments are utilized in spine surgical procedures to assist in location of the nerves during or after preparation and placement of implants (intervertebral fusion cages and pedicle screw fixation devices) in open and percutaneous minimally invasive approaches.Warnings/cautions/precautions: incorrect handling of these instruments may render them unsuitable for their intended use, cause corrosion, dismantling, distortion, breakage, or cause injury to the patient or user.Do not use the drills and taps at high speeds.

• Brand Name: ARCUS STIMULATING TARGETING NEEDLE, BEVEL TIP
• Common Device Name: NEUROSURGICAL NERVE LOCATOR
• 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: michael hendrickson ; 1950 camino vida roble; carlsbad, CA 92008 ; 7603566777
• MDR Report Key: 25032660
• Report Number: 2027467-2026-00074
• Device Sequence Number: 10260834
• Product Code: PDQ
• UDI-Device Identifier: 00190376240275
• UDI-Public: (01)00190376240275(10)10727803
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2026

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
• Operator of Device: Health Professional
• Device Model Number: 16122-02-S
• Device Catalogue Number: 16122-02-S
• Device Lot Number: 10727803
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/29/2026
• Supplement Report FDA Received Date: 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/01/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 68 YR
• Patient Sex: Male