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 06/16/2016

Event Type  malfunction  

Manufacturer Narrative

Return requested.Replacement probe 1.5 ball shipped to site 06/16/2016.Medtronic investigation of returned suspect probe finds the tip of the probe is visibly bent.Bent instrument tip - physical damage failure.Hardware investigation was completed.This issue was found related to a hardware issue and was documented in a medtronic hardware anomaly tracking database.No further issues have been reported.

Event Description

A medtronic representative reported that, while in a spine procedure, the surgeon noted the tip of the ball point planar probe was bent.This was discovered after piercing the cortical bone and exploring the hole with the ball tip probe.No further details regarding the damage, or how it occurred, were provided.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: amos jarrette ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902082
• MDR Report Key: 5782007
• MDR Text Key: 49153857
• Report Number: 1723170-2016-01372
• 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,Followup
• Report Date: 08/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2016
• 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: 150922
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2015
• 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: 66 YR
• Patient Weight: 106