MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. 5.5MM TAP (CANNULATED); ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number 9734300

Device Problems Bent (1059); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/05/2015

Event Type  malfunction  

Event Description

A medtronic representative reported that, while in a spine fusion procedure, a site's 5.5mm cannulated tap was bent.There was no delay in the procedure and the surgeon opted to continue.No further details regarding the damage, or how it occurred, were provided.The surgeon completed the procedure with the use of the navigation system.There was no impact on patient outcome.

Manufacturer Narrative

The site declined to provide patient information, referencing (b)(4) privacy laws.Return requested.Replacement 5.5mm tap (cannulated) shipped to site.No parts have been returned to manufacturer for analysis.

Manufacturer Narrative

Device manufacture date provided.The device was returned to the manufacturer for analysis.The returned tap was not found to be bent as reported.The instrument was in good condition with only minor impact marks on the back end.The instrument inserted and rotated in the handle without issue.The device was found to be fully functional.The reported event could not be duplicated by medtronic personnel.

Manufacturer Narrative

Correction: on 13-oct-2015, it was noticed that a previous mdr submission contained incorrect information with regards to the common device name, product code and/or pma/510(k).This mdr is being submitted to correct this information.There is no new information to change the patient information, event description or manufacturer narrative that was previously reported.

• Brand Name: 5.5MM TAP (CANNULATED)
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC.; 826 coal creek circle; louisville CO 80027 9710
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC.; 826 coal creek circle; louisville CO 80027 9710
• Manufacturer Contact: kristianna bilan ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902338
• MDR Report Key: 4572174
• MDR Text Key: 5478907
• Report Number: 1723170-2015-00273
• 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: Other,Foreign,Company Representative,company representati
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date: 11/10/2015

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: 9734300
• Device Lot Number: 130108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/03/2015
• Initial Date FDA Received: 03/05/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/01/2015; 11/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/08/2013
• 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