MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) DRIVER 9735025 SOLERA 5.5/6.0 RMAS; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number 9735025

Device Problems Bent (1059); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/16/2016

Event Type  malfunction  

Manufacturer Narrative

Site doctor (b)(6) declined to provide patient information.Device lot number is unavailable.Device manufacturing date is dependent on lot number, therefore, unavailable.Return requested.Replacement solera 5.5/6.0 driver shipped to site (b)(4)2016.No parts have been received by manufacturer for analysis.On (b)(4) 2017 a medtronic representative, following-up at the site, reported the instrument became bent during navigation and no inaccuracy was reported to medtronic representatives.

Event Description

A medtronic representative reported that, while in a spinal fusion procedure, a site's solera 5.5/6.0 driver had a bent tip.No further details regarding this issue, or specifically when it occurred, were provided.The surgeon completed the procedure with the use of the navigation system.Delay in therapy was less than one hour.There was no impact on patient outcome.

Manufacturer Narrative

The hardware investigation of the returned driver found that the reported event was related to a physical damage issue.The tip of the driver had been broken off.The driver was in otherwise good condition.The reported event was confirmed.This issue was documented in a medtronic navigation hardware anomaly tracking database.

Manufacturer Narrative

This device is included in the medical device field correction notification, "potential for instrument breaking ¿ medtronic navigated solera screwdrivers" (september 2015).The revised instructions for use (ifu) were also provided with the notification.

• Brand Name: DRIVER 9735025 SOLERA 5.5/6.0 RMAS
• 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 ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902082
• MDR Report Key: 6252037
• MDR Text Key: 64889158
• Report Number: 1723170-2017-00146
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K124004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Remedial Action: Relabeling
• Type of Report: Initial,Followup,Followup
• Report Date: 03/28/2017

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: 9735025
• Device Lot Number: 160916
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/16/2016
• Initial Date FDA Received: 01/13/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/09/2017; 03/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-2823/2824-2015
• Patient Sequence Number: 1