MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) UNIVERSAL DRILL GUIDE; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number 960-521

Device Problems Unstable (1667); Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/23/2016

Event Type  malfunction  

Manufacturer Narrative

Patient identifier, age and weight were not made available from the site.Device lot number not available.Device manufacturing date is dependent on lot number, therefore, unavailable.Return requested.Replacement device shipped to site.No parts have been received by manufacturer for analysis.No further issues have been reported.

Event Description

A medtronic representative reported that, while in a spine procedure, universal drill guide was being used, the cylinder/pipe was came off and detached from the grip.The cylinder/pipe was attached again and accuracy was checked.The surgeon opted to continue the procedure with this knowledge.The surgeon completed the procedure with the use of the navigation system.There was no delay of therapy.There was no impact on patient outcome.After the procedure was completed using navigation, the reported product was checked and it was noticed that the cylinder/pipe easily came off and detached by hand.The cylinder would not came off without manipulating forcefully.

Manufacturer Narrative

Device lot number now provided.Device manufacturing date now provided.Medtronic investigation of returned suspect universal drill guide finds that the guide tube has broken free of the handle and is easily removed.The handle is otherwise functional with no other apparent damage.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.

• Brand Name: UNIVERSAL DRILL GUIDE
• Type of Device: NEUROLOGICAL 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: kristianna bilan ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902338
• MDR Report Key: 5594482
• MDR Text Key: 43225052
• Report Number: 1723170-2016-00599
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K974161
• 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
• Type of Report: Initial,Followup
• Report Date: 05/20/2016

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: 960-521
• Device Lot Number: 367408
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/23/2016
• Initial Date FDA Received: 04/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2006
• 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