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

Catalog Number 9734403

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/04/2016

Event Type  malfunction  

Manufacturer Narrative

Patient identifier, age and weight were not made available from the site.Per (b)(4), site stealth technician representative, those patient demographic details are no longer available as they reported this to medtrronic well after the procedure took place.Date of event estimated at (b)(6) 2016.No specific event date was provided per the site reporting to the manufacturer ".Well after the case.They do not keep track of the patient information in these situations." return requested.Replacement thoracic probe shipped to site 01/27/2016.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 fusion procedure, the site noticed their thoracic probe was visibly bent.The site was able to verify the instrument and it was off.The site had multiple sets and another instrument was brought in to allow the surgeon to continue the procedure.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.Replacement requested.

Manufacturer Narrative

A medtronic representative, following up with the site, reported that the probe was noticeably bent when the site was preparing for the case so it is not possible when the damage to the probe occurred.Medtronic investigation of returned suspect device finds that as reported, the tip of the probe appears to be slightly bent.However, when attached to a known good navlock tracker, the probe verified without issue.The divot error was slightly elevated, but within normal range.The reported event was confirmed to be caused by physical 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: THORACIC PROBE TIP
• 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: kristianna bilan ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902338
• MDR Report Key: 5444256
• MDR Text Key: 38460233
• Report Number: 1723170-2016-00219
• Device Sequence Number: 1
• Product Code: OLO
• 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: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 03/21/2016

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: 9734403
• Device Lot Number: 120405
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/25/2016
• Initial Date FDA Received: 02/18/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/05/2012
• 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