MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. 5.5/6.0 SOLERA DRIVER; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number S7

Device Problems Loose or Intermittent Connection (1371); Poor Quality Image (1408); Improper Device Output (2953)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/03/2014

Event Type  malfunction  

Event Description

A medtronic representative reported that, while in a spine procedure, when using a navlock with a solera 5.5/6.0 driver, the screen wobbles when putting the screws in the bone by hand.No further details were provided.The surgeon completed the procedure with the use of the navigation system.There was no impact on patient outcome.

Manufacturer Narrative

Patient information was unavailable from the site.No parts have been returned to manufacturer for analysis.

Manufacturer Narrative

Patient information provided.Patient weight was not available from the site.Corrections: the issue was confirmed to be with the screw and not the screen.There was play (toggle) between the 5.5/6.0 mas driver and the head of the screw.Manual tightening did not seem to hold the screw head in place to accurately project the trajectory of the screw.The rep reported that the sleeve was not in good contact with the screw, and the surgeon needed to re-tighten the sleeve twice while manually putting the sleeve into the pedicle.No screws were not misplaced during the procedure.Correct device provided.Device manufacture date was unavailable as no lot number was provided.(b)(4).

Manufacturer Narrative

The software investigation found that the reported event was not related to a software issue.The user did not engage the head of the screw with the driver properly, which caused the navigation of the screw to change sporadically.The software functioned as designed.

Manufacturer Narrative

Correction: on 13-oct-2015, it was noticed that a previous mdr submission contained incorrect information with regards to the common device name, product code and/or pma/510(k).This mdr is being submitted to correct this information.There is no new information to change the patient information, event description or manufacturer narrative that was previously reported.

• Brand Name: 5.5/6.0 SOLERA DRIVER
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC.; 826 coal creek circle; louisville CO 80027 9710
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC.; 826 coal creek circle; louisville CO 80027 9710
• Manufacturer Contact: nicholas mcnabb ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902439
• MDR Report Key: 3902711
• MDR Text Key: 4427202
• Report Number: 1723170-2014-00695
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K124004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative,company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: S7
• Device Catalogue Number: 9735023
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2014
• 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
• Patient Age: 69 YR