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

Model Number 85-2481559

Device Problem Component Falling (1105)

Patient Problem No Information (3190)

Event Date 05/03/2018

Event Type  malfunction  

Event 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
• Type of Device: RONGEUR, MANUAL
• Manufacturer (Section D): AVALIGN TECHNOLOGIES, INC.; 8727 clinton park drive; fort wayne IN 46825
• MDR Report Key: 7586219
• MDR Text Key: 110600197
• Report Number: 7586219
• Device Sequence Number: 1
• Product Code: HAE
• UDI-Device Identifier: 00190776104733
• UDI-Public: (01)00190776104733
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 85-2481559
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/01/2018
• Event Location: Hospital
• Date Report to Manufacturer: 06/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NOT APPLICABLE.