MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTHSTATION¿ S8 SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number 9735667

Device Problems Mechanics Altered (2984); Output Problem (3005)

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

Event Date 01/24/2022

Event Type  malfunction  

Manufacturer Narrative

Patient information was unavailable from the site.No parts have been received by the manufacturer for evaluation.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system being used in a spinal fusion procedure.It was reported that the threaded screw fixation on the screw head was being used with the screwdriver.While being used it loosens while screwing the screw into the patient, because the soft tissue of the patient is in contact with the outer part of the screwdriver.This causes the navigation to loose precision, since the screwdriver and screw then have some clearance.To prevent loosening, the health care professional has to tighten the screw fixation several times while screwing in.The probable cause of the reported issue was thought to be the screwdriver design.The next step was to possibly change the design of the screwdriver and use a locking device as used with the non navigated screwdriver.To prevent the screw head fixation from unscrewing screwdriver.There was no delay to the case.No impact on patient outcome.Additional information was received stating that clarification was received stating that "causes the navigation to loose precision" mean that the navigation relies on the fact that the screwdriver and screw are tightened coaxial together.If the screw loosens physically and gets some angle to the screwdriver it defers from its virtual projection in the navigation.The health care professional (hcp) tightened the fixation between screw and screwdriver several times while inserting making it straight again.This didn't lead to any misplaced screws it just felt insecure.The hcp mentioned the desire for a locking device.

• Brand Name: STEALTHSTATION¿ S8 SYSTEM
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 13524951
• MDR Text Key: 286597764
• Report Number: 1723170-2022-00193
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00763000359782
• UDI-Public: 00763000359782
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K162309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9735667
• Device Catalogue Number: 9735667
• Device Lot Number: N30513605
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/14/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1