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

Catalog Number 9734403

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/12/2017

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2017 a replacement probe was shipped.Replacement probe resolved the issue.No further issues were reported.The suspected probe was returned to manufacturer for evaluation.Testing found that the tip of the probe was twisted severely.The hardware investigation found that the reported event was related to a hardware issue.This issue was documented in a medtronic navigation hardware anomaly tracking database.

Event Description

A medtronic representative reported that during a spinal fusion procedure with navigation system a navlock thoracic probe was found to have bent tip.There was no delay to the procedure.The procedure was completed with the use of navigation system.No impact on patient outcome.

• Brand Name: THORACIC 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: prashanth gali ; attn:product quality experienc; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902515
• MDR Report Key: 6630225
• MDR Text Key: 77429814
• Report Number: 1723170-2017-02415
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00613994724014
• UDI-Public: 00613994724014
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K124004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 06/09/2017

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: 9734403
• Device Lot Number: 111102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/12/2017
• Initial Date FDA Received: 06/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/02/2011
• 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