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

Catalog Number 960-559

Device Problem Bent (1059)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/30/2017

Event Type  malfunction  

Manufacturer Narrative

Device manufacturing date is dependent on lot number therefore, unavailable.Medtronic representative was present on the site when the reported event occurred and the damage to the probe was confirmed by him.Replacement of the probe resolved the issue.No further issues were reported.The damaged probe was not returned to manufacturer for analysis, therefore, no findings are possible.Part not returned.

Event Description

A medtronic representative reported that while in a spinal fusion procedure, the passive planar ball probe became bent.The procedure continued using another probe.There was a reported delay to the procedure of less than 1 hour due to this issue.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: sam saleh ; 826 coal creek circle; louisville, CO 80027
• MDR Report Key: 6352773
• MDR Text Key: 68136684
• Report Number: 1723170-2017-00848
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00673978090153
• UDI-Public: 00673978090153
• 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,user f
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2017
• 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?: Yes
• Date Manufacturer Received: 01/30/2017
• 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
• Patient Age: 19 YR
• Patient Weight: 59