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

Model Number 16122-02-S

Device Problem Fracture (1260)

Patient Problem Insufficient Information (4580)

Event Date 07/12/2021

Event Type  malfunction  

Manufacturer Narrative

The returned device is currently being evaluated.A follow up report with results of the investigation will be submitted upon completion.

Event 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.

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
• Type of Device: 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
• MDR Text Key: 267530128
• Report Number: 2027467-2021-00056
• Device Sequence Number: 1
• Product Code: PDQ
• UDI-Device Identifier: 00190376240275
• UDI-Public: 00190376240275
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191723
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Initial Date Manufacturer Received: 07/16/2021
• Initial Date FDA Received: 08/10/2021
• Supplement Dates Manufacturer Received: 07/16/2021
• Supplement Dates FDA Received: 12/14/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/23/2001
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1