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

Catalog Number 9734680

Device Problems Mechanical Problem (1384); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/17/2018

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 the manufacturer for evaluation.Art not returned for analysis.

Event Description

A site representative reported that, while in a spinal fusion, the tip of the probe was reported to have twisted off and that the site was unable to remove the tip as the tip went further into the sacroiliac joint and remained in the ilium.It was reported that prior to the issue, the site attempted to hammer a separate manufacturer's probe into the pedicle that subsequently bent.It was noted that the medtronic probe was also hammered into the pedicle by the surgeon.The probe was then forcibly rotated, leading to the tip breaking off.The site alleged no allegation of deficiency against the medtronic product and felt that the issue was caused by the surgeon.There was no reported delay to the procedure due to this issue.No additional information was provided.There was no impact on patient outcome.

Manufacturer Narrative

Additional information: a medtronic representative reported that the tip of the probe remained in the patient as the tip traveled deeper into the sacroiliac joint.

• 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: peter verhey ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710
• MDR Report Key: 7259786
• MDR Text Key: 99919765
• Report Number: 1723170-2018-00617
• Device Sequence Number: 1
• Product Code: OLO
• 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
• Report Date: 03/28/2018

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: 9734680
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/17/2018
• Initial Date FDA Received: 02/09/2018
• Supplement Dates Manufacturer Received: 03/22/2018
• Supplement Dates FDA Received: 03/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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