MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. 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 10/03/2014

Event Type  malfunction  

Event Description

A medtronic representative reported that a pedicle probe instrument was bent during a spine procedure.The surgeon completed the procedure with the use of the navigation system.There was no impact on patient outcome.

Manufacturer Narrative

Patient identifier field not sufficient to hold all digits, should read: (b)(6).Patient weight not available from the site.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 analysis.Not returned to manufacturer.

Manufacturer Narrative

Lot number and device manufacture date provided.The device was returned to the manufacturer for analysis and showed signs of physical damage.As reported, the tip of the probe was bent and difficult to register.The reported event was confirmed.The most likely cause of the report was over-torquing the device during use.The device was replaced to resolve the issue.

• Brand Name: 2.25 MM PEDICLE PROBE
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC.; 826 coal creek circle; louisville CO 80027 971
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC.; 826 coal creek circle; louisville CO 80027 971
• Manufacturer Contact: amos jarrette ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902082
• MDR Report Key: 4203486
• MDR Text Key: 4964166
• Report Number: 1723170-2014-01161
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 10/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 9733457
• Device Lot Number: 100929
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/01/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2010
• 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
• Patient Age: 62 YR