MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC INST 960-539 GUIDE BIOPSY; INSTRUMENT, STEREOTAXIC

Model Number 960-539

Device Problems Material Integrity Problem (2978); Output Problem (3005)

Patient Problem No Patient Involvement (2645)

Event Date 06/18/2020

Event Type  malfunction  

Manufacturer Narrative

Manufacture date not available on the date of filing.The instrument was returned to the manufacturer for analysis.The reported issue was confirmed, the lower joint will not lock down completely when the knob is tightened.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system.It was reported that the nac tray precision aiming device (pad) will not fully tighten.There was no patient involvement.

• Brand Name: INST 960-539 GUIDE BIOPSY
• Type of Device: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: tricha miles ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635140379
• MDR Report Key: 10257749
• MDR Text Key: 198383985
• Report Number: 1723170-2020-01896
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K954276
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 960-539
• Device Catalogue Number: 960-539
• Device Lot Number: 106031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2020
• Date Manufacturer Received: 06/18/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1