MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) SURETRAK II UNIVERSAL TRACKER, SMALL PASSIVE FIGHTER; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number 9731567

Device Problem Calibration Problem (2890)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/03/2018

Event Type  malfunction  

Manufacturer Narrative

Unique device identification (udi) is not available.Device lot number, or serial number, unavailable.Device manufacturing date is dependent on lot number/serial number, therefore, unavailable.No parts have been received by the manufacturer for evaluation.

Event Description

Medtronic received information regarding a navigation system.It was reported that intra/peri-operatively during the navigate task of a sacroiliac and thoracolumbar procedure, the site used an orange tracker and a driver and it was accurate, however; during the case calibration was lost.The site chose to use a tracker with the grey on the driver.The site stated it wasn't loose and after investigating the orange tracker it had been heavily used.There was no delay to the procedure.No known impact on patient outcome.

• Brand Name: SURETRAK II UNIVERSAL TRACKER, SMALL PASSIVE FIGHTER
• 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: prashanth gali ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902515
• MDR Report Key: 7718500
• MDR Text Key: 115065014
• Report Number: 1723170-2018-03687
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K983670
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9731567
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/03/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 74 YR
• Patient Weight: 82