MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC DRIVER 9734228 GRAY ASSY; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number 9734228

Device Problem Material Integrity Problem (2978)

Patient Problem No Patient Involvement (2645)

Event Date 11/29/2018

Event Type  malfunction  

Manufacturer Narrative

The driver was returned to the manufacturer for analysis.Analysis found that the post on one of the support arms of the driver was missing.Otherwise, with the remaining markers attached and fully seated, the driver returned good geometry and divot error readings.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.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation device being used outside a procedure.It was reported that the gray navlock driver was damaged.There was no patient present when this issue was identified.

• Brand Name: DRIVER 9734228 GRAY ASSY
• Type of Device: ORTHOPEDIC 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: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 8201770
• MDR Text Key: 131588967
• Report Number: 1723170-2018-06479
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00613994671820
• UDI-Public: 00613994671820
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9734228
• Device Catalogue Number: 9734228
• Device Lot Number: 170302
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2017
• 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