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

Catalog Number 9734680

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/27/2017

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2017 a replacement probe was shipped to site.The suspect part has been not received by manufacturer for evaluation.Part not returned for evaluation.

Event Description

A medtronic representative reported that during a spinal fusion procedure a navlock thoracic probe was bent.The bend occurred when using the probe to make a screw hole through patient pedicle.The surgeon hammered the handle to get the probe into the bone and turned the probe to widen the hole.When the surgeon turned the probe the bone was hard it twisted the tip of the probe.Surgeon used a lumbar probe instead.The surgery was completed with the use of navigation.There was no delay to the procedure.No impact on patient outcome.

Manufacturer Narrative

The hardware investigation of the returned probe found that the reported event was related to a physical damage issue.As reported, the tip of the probe had been severely twisted.Also, the probe was returned inserted into a navlock tracker and could not be removed.Was able to separate the two parts to find impact marks at the back end of the probe causing fit issues.The reported event was confirmed.This issue was documented in a medtronic navigation hardware anomaly tracking database.

• Brand Name: NAV 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: amos jarrette ; 826 coal creek circle; attn:product quality experienc; louisville, CO 80027-9710 ; 7208902082
• MDR Report Key: 6742575
• MDR Text Key: 80988571
• Report Number: 1723170-2017-03031
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00613994870063
• UDI-Public: 00613994870063
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K124004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 09/01/2017

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: 9734680
• Device Lot Number: 170522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/27/2017
• Initial Date FDA Received: 07/25/2017
• Supplement Dates Manufacturer Received: 08/03/2017
• Supplement Dates FDA Received: 09/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/22/2017
• 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: 51 YR
• Patient Weight: 104