MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. 3.75MM TAP (NON-CANNULATED); ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number 9734296

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/18/2015

Event Type  malfunction  

Event Description

A medtronic representative reported that, while in a spine procedure, the surgeon was removing the 3.75 tap, torqued it too hard and bent the tip of the tap.No further details regarding the damage, or how it occurred, were provided.As this was the last screw to be placed, there was no delay to the procedure.The surgeon completed the procedure with the use of the navigation system.There was no impact on patient outcome.

Manufacturer Narrative

Device lot number, or serial number, not available.Device manufacturing date is dependent on lot number/serial number, therefore, unavailable.Return requested.Replacement device shipped to site (b)(4) 2015.No parts have been returned to manufacturer for analysis.

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: 3.75MM TAP (NON-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: 4606504
• MDR Text Key: 17587318
• Report Number: 1723170-2015-00324
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K124004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative,company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,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: 9734296
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/18/2015
• Initial Date FDA Received: 03/16/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/10/2015
• 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
• Patient Age: 17 YR
• Patient Weight: 117