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

Model Number	9560565
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: MICROPITUITARY RONGEUR
• Manufacturer (Section D): AVALIGN GERMANY SPECIALITY INSTRUMENTS; 626 cooper ct; schaumburg IL 60173
• MDR Report Key: 11393372
• Report Number: 1421101-2021-00001
• Device Sequence Number: 19672920
• Product Code: HAE
• UDI-Device Identifier: 00190776114596
• UDI-Public: 00190776114596
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/01/2021

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: No Information
• Device Model Number: 9560565
• Device Catalogue Number: 31-9560565
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/01/2021
• Patient Sequence Number: 1