MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) TERATRACKER, PURPLE; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number	9730492
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The hospital has not provided a purchase order number to replace the allegedly damaged item, nor have they returned it.No further evaluation possible.Device mfg date was not available at the time of this report.Not returned by customer.
Event or Problem Description
A hospital representative reported that the teratracker screw was stripped and would no longer tighten down.No patient involvement.
Additional Manufacturer Narrative
Additional information: device manufacture date provided.Correction: lot number updated to proper value.

• Brand Name: TERATRACKER, PURPLE
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 6871438
• Report Number: 1723170-2017-03800
• Device Sequence Number: 10921751
• Product Code: HAW
• UDI-Device Identifier: 00721902652295
• UDI-Public: 00721902652295
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K050651
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Hospital Service Technician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2017

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: 9730492
• Device Lot Number: 200508055991
• Initial Date Received by Manufacturer: 08/18/2017
• Supplement Date Received by Manufacturer: 09/18/2017
• Initial Report FDA Received Date: 09/17/2017
• Supplement Report FDA Received Date: 10/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1