MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) NAV 4.5MM TAP (CANNULATED); ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number 9734238

Device Problem Bent (1059)

Patient Problem No Patient Involvement (2645)

Event Date 05/08/2018

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.Lot no.And manufacture date not available for this system at time of filing.No parts have been received by the manufacturer for evaluation.

Event Description

Medtronic received information regarding a navigation device being used outside a procedure.It was reported that the cannulated tap was bent.There was no patient present when this issue was identified.

• Brand Name: NAV 4.5MM TAP (CANNULATED)
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: tiberious mose ; navigation customer quality; 826 coal creek circle; louisville, CO 80027
• MDR Report Key: 7565913
• MDR Text Key: 109947702
• Report Number: 1723170-2018-02448
• 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: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 06/04/2018

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: 9734238
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/08/2018
• Initial Date FDA Received: 06/04/2018
• 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