MAUDE Adverse Event Report: MEDTRONIC METRX 2MM MICROPITUITARY

Catalog Number 9569567

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/05/2017

Event Type  malfunction  

Event Description

Micro upbiting pituitary instrument in metrx tray broke apart.Unable to retrieve broken piece.

• Brand Name: METRX 2MM MICROPITUITARY
• Type of Device: METRX 2MM MICROPITUITARY
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 6479928
• MDR Text Key: 72584978
• Report Number: MW5068997
• Device Sequence Number: 1
• Product Code: HTX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9569567
• Device Lot Number: GZ14G011
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: PLEASE SEND INFO TO THE MFR
• Patient Outcome(s): Other
• Patient Age: 31 YR