MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) 6.5MM TAP (CANNULATED); ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	9734302
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/13/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient was involved in this concern.Part was not replaced or returned despite multiple attempts by the manufacturer to complete the return materials authorization process.This device is included in the medical device field correction notification, "potential for user injury ¿ medtronic navigated cannulated taps" (may 2015).The revised instructions for use (ifu) were also provided with the notification.
Event or Problem Description
A medtronic representative reported that a solera 6.5 tap had a guide wire stuck inside.No patient or user harm reported.This issue was discovered outside of surgical use.

• Brand Name: 6.5MM TAP (CANNULATED)
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 6398498
• Report Number: 1723170-2017-01127
• Device Sequence Number: 36873
• Product Code: OLO
• UDI-Device Identifier: 00613994724052
• UDI-Public: 00613994724052
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K124004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Remedial Action: Notification,Relabeling
• Type of Report: Initial
• Report Date (Section B): 03/13/2017

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
• Operator of Device: Health Professional
• Device Catalogue Number: 9734302
• Device Lot Number: 110628
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2016
• Initial Report FDA Received Date: 03/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1847-2015
• Patient Sequence Number: 1