MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) PASSIVE PLANAR BALL 1.5MM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number 960-559

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/16/2016

Event Type  malfunction  

Manufacturer Narrative

Site representative declined to provide patient identifier, age and weight per medtronic representative following up at the site on 07/27/2016.Device lot number were not available from the site.Device manufacturing date is dependent on lot number, therefore, unavailable.Return requested.Replacement passive planar ball 1.5mm shipped to site 07/21/2016.No parts have been received by manufacturer for analysis.Site declined to return suspect passive planar ball 1.5mm for analysis.On 07/27/2016 a medtronic representative, following-up at the site, reported the instrument registered and was accurate, however, there is a noticeable bend at the distal end of the instrument.

Event Description

A medtronic representative received a report from a site that while in a spine procedure, the tip of their probe was bent, which has caused the surgeon to question it's accuracy.The probe registers fine and there have not been any issues.No further details regarding the damage, or how it occurred, were provided.A replacement probe was requested.The surgeon opted to continue and completed the procedure with the use of the navigation system.Delay in therapy was less than one hour.There was no impact on patient outcome.

• Brand Name: PASSIVE PLANAR BALL 1.5MM
• Type of Device: NEUROLOGICAL 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: judith ericson ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902187
• MDR Report Key: 5870730
• MDR Text Key: 51932113
• Report Number: 1723170-2016-02076
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K972398
• 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
• Report Date: 08/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 960-559
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/16/2016
• 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