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

Model Number	16122-02-S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned device is currently being evaluated.A follow up report with results of the investigation will be submitted upon completion.
Event or Problem Description
The targeting needle got stuck in sclerotic bone and broke which caused a delay in surgery.All pieces were removed from the patient.No patient injury reported.
Additional Manufacturer Narrative
H6: medical device problem code:1260 component code:752 type of investigation: 3331; 10 investigation findings:3252 investigations conclusions: 23 device evaluation: the device history record was reviewed.No irregularities were identified during manufacturing or inspection.The device returned on 07/16/2021.Visual inspection of the device confirmed the event.The top portion has completely de-attached from the device.The device was not returned for evaluation.A photograph was provided to confirm the event.The root cause is the result of the cannula hub interface yields/strips at a lower force than the force required to remove the product from bone.This is likely result related to the manufacturing process.

• Brand Name: ARCUS GUIDED ACCESS SYSTEM - BEVEL TIP, STERILE
• Common Device Name: NEUROSURGICAL NERVE LOCATOR
• Manufacturer (Section D): ALPHATEC SPINE, INC; 1950 camino vida roble; carlsbad CA 92008
• Manufacturer Contact: jayson alaba ; 1950 camino vida roble; carlsbad, CA 92008 ; 7604946771
• MDR Report Key: 12304883
• Report Number: 2027467-2021-00056
• Device Sequence Number: 14548325
• Product Code: PDQ
• UDI-Device Identifier: 00190376240275
• UDI-Public: 00190376240275
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,Followup
• 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
• Device Model Number: 16122-02-S
• Device Catalogue Number: 16122-02-S
• Device Lot Number: 210671991
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2021
• Supplement Date Received by Manufacturer: 07/16/2021
• Initial Report FDA Received Date: 08/10/2021
• Supplement Report FDA Received Date: 12/14/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/23/2001
• 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
• Patient Sex: Unknown