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 05/19/2016

Event Type  malfunction  

Manufacturer Narrative

Patient identifier field not sufficient to hold all digits, should read: (b)(4).Patient weight not made available from the site.Return requested.Replacement passive planar ball 1.5mm shipped to site 05/19/2016.Medtronic investigation of returned suspect passive planar ball 1.5mm found the ball tip to be slightly bent, however, the divot error read 1.4mm which is still within specifications.Geometry error was also within specification.Checked all functions of the planar with no failures.No fault found.No further issues have been reported.

Event Description

A medtronic representative reported that, while in a spine procedure, the surgeon noted that their passive planar ball tip probe was slightly bent.The surgeon continued to use the probe, however, requested a new one be purchased.No further details regarding the damage, or how it occurred, were provided.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.

• 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: 5726561
• MDR Text Key: 47495342
• Report Number: 1723170-2016-01078
• 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: 06/15/2016

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: 960-559
• Device Lot Number: 5122811476
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/19/2016
• Initial Date FDA Received: 06/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/28/2005
• 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: 64 YR