MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) LEFT THORACIC TACTILE PROBE; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number 9734436

Device Problems Bent (1059); Mechanical Problem (1384)

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

Event Date 02/02/2017

Event Type  malfunction  

Manufacturer Narrative

Patient identifier not available from the site.Patient weight not available from the site.No parts have been received by the manufacturer for evaluation.This report was generated from the incident reported in mdr filing number 1723170-2017-00906.

Event Description

A medtronic representative reported that the instrument was damaged while attempting to place the screws in a spinal pedical screw fixation procedure.It was noted that the patient's bone was extremely hard and the instruments were not easily passing through the bone as they should have.There was no patient impact reported and the delay in surgery was over an hour.Surgery proceeded as planned.

Manufacturer Narrative

Upon further follow-up, it was reported that the instrument was bent.There was an inaccuracy because navigation was completely lost because where the navigation system was saying the surgeon was and where he actually was different.The pedicle was not breached due to this issue.The issue was resolved by using a none navigated instrument.

• Brand Name: LEFT THORACIC TACTILE PROBE
• 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: oksana ditolla ; attn:product quality experienc; 826 coal creek circle; louisville, CO 80027-9710
• MDR Report Key: 6368446
• MDR Text Key: 68770990
• Report Number: 1723170-2017-00804
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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
• Type of Report: Initial,Followup
• Report Date: 07/13/2017

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: 9734436
• Device Lot Number: 150701
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/02/2017
• Initial Date FDA Received: 03/01/2017
• Supplement Dates Manufacturer Received: 06/19/2017
• Supplement Dates FDA Received: 07/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2015
• 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: 79 YR