MAUDE Adverse Event Report: AVALIGN GERMANY SPECIALITY INSTRUMENTS MILLENNIUM MICROPITUITARY RONGEUR

Model Number 9560565

Device Problem Material Fragmentation (1261)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Unable to confirm lot number of this device. Trend analysis completed; device history record review not possible as lot number could not be confirmed.

Event Description

During a lumber fusion surgical procedure the micropituitary rongeur broke, a fragment broke off, surgeon was able to retrieve the fragment.

• Brand Name: MILLENNIUM
• Type of Device: MICROPITUITARY RONGEUR
• Manufacturer (Section D): AVALIGN GERMANY SPECIALITY INSTRUMENTS; 626 cooper ct; schaumburg IL 60173
• MDR Report Key: 11393372
• MDR Text Key: 246274467
• Report Number: 1421101-2021-00001
• Device Sequence Number: 1
• Product Code: HAE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 03/01/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 03/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 9560565
• Device Catalogue Number: 31-9560565
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No Answer Provided

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage