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

Catalog Number 9734679

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/02/2015

Event Type  malfunction  

Manufacturer Narrative

Return requested.Medtronic investigation of returned suspect device finds that, as reported, the tip of the probe is bent.Also, there are impact marks and rolled edges on the back end of the instrument causing fit issues with the mating navlock tracker.Physical damage - bent instrument tip.Hardware investigation was completed.This issue was found related to a hardware issue and was documented in a medtronic hardware anomaly tracking database.10/05/2015 a medtronic representative, following-up at the site, reported the surgeon asked the scrub technician to clear away instruments and the scrub tech removed the probe.The scrub tech was not able to take the navlock off the probe and asked the medtronic representative to do it, this is when the damage was noticed.

Event Description

A medtronic representative reported that, while in a spine procedure, the site discovered they had a bent lumbar probe.No further details regarding the damage, or how it occurred, were provided.There was no patient present when this issue was identified.

Manufacturer Narrative

Correction: on 13-oct-2015, it was noticed that a previous mdr submission contained incorrect information with regards to the common device name, product code and/or pma/510(k).This mdr is being submitted to correct this information.There is no new information to change the patient information, event description or manufacturer narrative that was previously reported.

• Brand Name: NAV LUMBAR 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: arsalan rizvi ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902460
• MDR Report Key: 5189307
• MDR Text Key: 29924740
• Report Number: 1723170-2015-01316
• 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: 11/09/2015

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: 9734679
• Device Lot Number: 150416
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/02/2015
• Initial Date FDA Received: 10/29/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/16/2015
• 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: 52 YR
• Patient Weight: 61