MAUDE Adverse Event Report: NAVINETICS NN1215 SKULL ANCHOR KEY AND DRILL KIT; STEREOTACTIC SYSTEM

Model Number NN1000

Device Problems Fitting Problem (2183); Defective Component (2292)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/26/2024

Event Type  malfunction  

Manufacturer Narrative

Product defect was dected by user prior to any adverse effect to the patient.All defective product determined to be linked to manufacturing/inspection issue, and all product of same lot # subject to removal.

Event Description

After attachment of the skull anchor key to the patient the user was unable to fully screw in the four thumbscrews of the localizer and securely attach the ct localizer onto the skull anchor key.Inability to fully secure the localizer resulted in a procedural delay, with user and field rep ultimately shortening the thumbscrews of the ct localizer to securely attach the two components in order to perform stereotactic imaging and continue with the procedure.

• Brand Name: NN1215 SKULL ANCHOR KEY AND DRILL KIT
• Type of Device: STEREOTACTIC SYSTEM
• Manufacturer (Section D): NAVINETICS; 206 s broadway; suite 700; rochester 55902
• Manufacturer (Section G): NAVINETICS; 206 south broadway; suite 700; rochester MN 55902
• Manufacturer Contact: danielle jondal ; 206 s broadway; suite 700; rochester, MN 55902 ; 5073613570
• MDR Report Key: 18793848
• MDR Text Key: 337517713
• Report Number: 3023194190-2024-70003
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K231392
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 02/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NN1000
• Device Catalogue Number: NN1215
• Device Lot Number: 331401724
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/17/2024
• 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
• Patient Sex: Prefer Not To Disclose