MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) DRIVER 9735024 SOLERA 5.5/6.0 MAS CANN; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number 9735024

Device Problems Device Operates Differently Than Expected (2913); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/12/2018

Event Type  malfunction  

Manufacturer Narrative

Patient identifier not available from the site.Patient weight not available from the site.The suspect driver was returned to the manufacturer for evaluation.It was reported that the tip of the instrument was deformed resulting in damages on the sides.The hardware investigation found that the reported event was related to a hardware issue.This issue was documented in a medtronic navigation hardware anomaly tracking database.

Event Description

A site representative reported that, while in a spinal fusion, the end of the screw driver being used could not engage with the screw intermittently.There was no reported delay to the procedure due to this issue.There was no impact on patient outcome.No additional information was provided.

• Brand Name: DRIVER 9735024 SOLERA 5.5/6.0 MAS CANN
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: peter verhey ; attn:product quality experienc; 826 coal creek circle; louisville, CO 80027-9710
• MDR Report Key: 7243933
• MDR Text Key: 99103420
• Report Number: 1723170-2018-00516
• 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: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/06/2018

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 Operator: Physician
• Device Catalogue Number: 9735024
• Device Lot Number: 170415
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/12/2018
• Initial Date FDA Received: 02/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/15/2017
• 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: 45 YR