MAUDE Adverse Event Report: AVALIGN TECHNOLOGIES, INC. MILLENNIUM; DRILL BIT

Model Number	85-1511023
Medical Device Problem Codes	Fracture (1260); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint device has not been returned to avalign technologies as of 24 oct 2023.Based on the photos provided with the complaint, the defect was able to be confirmed.As the complaint photo only included the broken tip of the drill bit, nothing could be determined regarding the use of this device.Complaint product was from lot 111419.There were 2 potential shipments identified for the complaint device: invoice #(b)(4) was shipped on 11/10/2022 (1 unit).Invoice #(b)(4) was shipped on 1/18/2023 (6 units).Review of ncmr and complaint data for 85-1511023 was completed on 18 oct 2023.During the review 0 complaints or ncmrs were identified.Dhr review for lot 111419 determined that all manufacturing records were correct and complete.No discrepancies were identified which would have resulted in the above complaint record.
Event or Problem Description
During a right total knee arthroplasty, approximately 1 cm of the tip of the drill bit (millennium 85-1511023 1.5mm) was retained in the distal femur.

• Brand Name: MILLENNIUM
• Common Device Name: DRILL BIT
• Manufacturer (Section D): AVALIGN TECHNOLOGIES, INC.; 8727 clinton park drive; fort wayne IN 46825
• Manufacturer Contact: jennifer staunton ; 8727 clinton park drive; fort wayne, IN 46825
• MDR Report Key: 18139859
• Report Number: 3008864603-2023-00001
• Device Sequence Number: 8045035
• Product Code: HTW
• UDI-Device Identifier: 00190776118211
• UDI-Public: 00190776118211
• 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
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial

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?: No
• Device Model Number: 85-1511023
• Device Lot Number: 111419
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2023
• Initial Report FDA Received Date: 11/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown