MAUDE Adverse Event Report: AVALIGN TECHNOLOGIES, INC. MILLENNIUM; RONGEUR, MANUAL

Model Number	85-2481559
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/03/2018
Type of Reportable Event	Malfunction
Event or Problem Description
A screw from the kerrison #3 fell out on the surgical field.The screw and the two separate portions of the instrument were removed from the surgical field and an x-ray of the surgical site was taken and read as clear by radiologist per policy.

• Brand Name: MILLENNIUM
• Common Device Name: RONGEUR, MANUAL
• Manufacturer (Section D): AVALIGN TECHNOLOGIES, INC.; 8727 clinton park drive; fort wayne IN 46825
• MDR Report Key: 7586219
• Report Number: 7586219
• Device Sequence Number: 1946459
• Product Code: HAE
• UDI-Device Identifier: 00190776104733
• UDI-Public: (01)00190776104733
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/01/2018
• Report Date (Section F): 06/01/2018

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
• Operator of Device: Physician
• Device Model Number: 85-2481559
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/01/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NOT APPLICABLE.
• Date Report Sent to FDA: 06/01/2018