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

Catalog Number 9734913

Device Problem Bent (1059)

Patient Problem No Patient Involvement (2645)

Event Date 05/14/2018

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.Lot no.And manufacture date not available for this instrument at time of filing.No parts have been returned to the manufacturer for evaluation.

Event Description

Medtronic received information that, while outside of a procedure, the thoracic probe for the site was bent.There was no patient present when this issue was identified.No additional information was provided.

Manufacturer Narrative

Additional information: device lot number provided.The probe was returned to the manufacturer for evaluation.Testing found that the tip of the probe was not bent.However, it was noted that impact marks at the back end led to fit issues with trackers.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.

Manufacturer Narrative

Additional information: unique device identification (udi) and device manufacture date provided.

• Brand Name: INST KIT PROBE THORACIC ASSY
• 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 ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710
• MDR Report Key: 7575254
• MDR Text Key: 110333547
• Report Number: 1723170-2018-02550
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00643169636095
• UDI-Public: 00643169636095
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/04/2018

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: 9734913
• Device Lot Number: 170606
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/14/2018
• Initial Date FDA Received: 06/06/2018
• Supplement Dates Manufacturer Received: 08/07/2018; 08/28/2018
• Supplement Dates FDA Received: 08/28/2018; 09/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2017
• 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