MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) 2.25 MM PEDICLE PROBE; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number 9733457

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/23/2017

Event Type  malfunction  

Manufacturer Narrative

Patient information not provided due to japanese patient privacy regulations.Device lot number, or serial number, unavailable.) device manufacturing date is dependent on lot number/serial number, therefore, unavailable.No parts have been received by manufacturer for evaluation.Part not returned for evaluation.

Event Description

A medtronic representative reported that during a spinal fusion procedure the tip of the cervical probe was bent.Site used another probe to complete the procedure.The procedure was completed with the use of navigation.There was no delay to the procedure.No impact on patient outcome.

Manufacturer Narrative

Additional information: device lot number and manufacturer date provided.The suspect probe was returned to the manufacturer for evaluation.Testing found that the probe was slightly bent and that it passed functional testing.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.

• Brand Name: 2.25 MM PEDICLE PROBE
• 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: peter verhey ; attn:product quality experienc; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902515
• MDR Report Key: 6872920
• MDR Text Key: 86492581
• Report Number: 1723170-2017-03796
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00613994335968
• UDI-Public: 00613994335968
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K050438
• 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,Followup
• Report Date: 12/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 9733457
• Device Lot Number: 160405
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/05/2016
• 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