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 Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not returned.If any additional information is provided, a supplemental report will be submitted.
Event or Problem Description
A targeting needle broke in the patient while being used by the surgeon.All pieces were recovered.No patient injury reported.
Additional Manufacturer Narrative
The following information was provided by the sales representative regarding this investigation: the patient had extremely hard bone which required lots of extra malleating.When the surgeon was malleating, the distal tip of the sheath broke off and was easily retrieved.No patient injury reported.The device has not returned to atec.If any additional information is provided, a supplemental report will be submitted.

• 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
• MDR Report Key: 12360431
• Report Number: 2027467-2021-00059
• Device Sequence Number: 11731026
• Product Code: PDQ
• UDI-Device Identifier: 00190376240275
• UDI-Public: 00190376240275
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2021

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: No Information
• Device Model Number: 16122-02-S
• Device Catalogue Number: 16122-02-S
• Device Lot Number: SH211243488
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/26/2021
• Supplement Date Received by Manufacturer: 07/26/2021
• Initial Report FDA Received Date: 08/24/2021
• Supplement Report FDA Received Date: 09/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other