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 08/25/2017

Event Type  malfunction  

Manufacturer Narrative

The suspect thoracic probe has been received by manufacturer for evaluation.Testing found that the tip of the probe had nicks and was bent to one side.The back end of the probe had several impact marks not allowing the probe to insert into the mating navlock tracker.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 while in navigation when using the thoracic probe to start entry point in the bone the tip of the probe bent.The surgeon completed the procedure with another probe.The procedure was completed with the use of navigation.There was a delay of less than 1 hour.No impact on patient outcome.

Manufacturer Narrative

Correction: unique device identification (udi) updated to proper value.

• 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: peter verhey ; attn:product quality experienc; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902515
• MDR Report Key: 6887420
• MDR Text Key: 87877860
• Report Number: 1723170-2017-03876
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00763000053796
• UDI-Public: 00763000053796
• 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: 10/24/2017

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: 100323
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/25/2017
• Initial Date FDA Received: 09/22/2017
• Supplement Dates Manufacturer Received: 10/24/2017
• Supplement Dates FDA Received: 10/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2010
• 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