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

Catalog Number 9734680

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/14/2016

Event Type  malfunction  

Manufacturer Narrative

Site neuro spine coordinator, r.R.Declined to provide patient demographic information.Return requested.Replacement navlock thoracic probe shipped to site 01/20/2016.No parts have been received by manufacturer for analysis.

Event Description

A medtronic representative reported that, while in a spine procedure, the patient's bone was hard and the site's thoracic probe was bent.No further details regarding the damage, or how it occurred, were provided.A second instrument was brought in to be used to continue the procedure to completion.There was no delay of therapy.There was no impact on patient outcome.

Manufacturer Narrative

Medtronic investigation of returned suspect device finds that the tip of the probe has been bent.Otherwise, the probe is in good condition.The lot code indicates this part was manufacture almost four and a half years ago.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: NAV 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: 5414312
• MDR Text Key: 37618165
• Report Number: 1723170-2016-00167
• 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: 04/01/2016

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: 9734680
• Device Lot Number: 111021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/14/2016
• Initial Date FDA Received: 02/05/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2011
• 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