MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) LEFT LUMBAR TACTILE PROBE; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number 9734434

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/30/2016

Event Type  malfunction  

Manufacturer Narrative

The site declined to provide patient information, per (b)(4) privacy laws.Return requested for suspect left lumbar tactile probe.No parts have been received by manufacturer for analysis.On 09/01/2016, a medtronic representative, following-up at the site, reported the tactile probe was bent upon insertion, the patient had incredibly hard bone.The surgeon switched to thoracic probes and continued the procedure.

Event Description

A medtronic representative reported that, while in a spinal fusion procedure, the tip of the tactile probe was bent.No further details regarding this issue, or specifically when it occurred, were provided.A different probe was brought in to allow the surgeon to continue.The surgeon completed the procedure with the use of the navigation system.There was no delay of therapy.There was no impact on patient outcome.

Manufacturer Narrative

Investigation of returned suspect lumbar probe finds that as reported, the tip of the probe is visibly bent.However, with a known good tracker attached, the probe returned good divot error.The reported issue was confirmed to be caused by physical damage.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: LEFT LUMBAR TACTILE PROBE
• 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: kristianna bilan ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902338
• MDR Report Key: 5981514
• MDR Text Key: 55791968
• Report Number: 1723170-2016-02373
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K124004
• 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: 11/16/2016

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: 9734434
• Device Lot Number: 120730
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/30/2016
• Initial Date FDA Received: 09/27/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2012
• 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