MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; TIBIAL HINGE COMPONENT, W/O STOP

Model Number	25002101E
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The root cause for the failure was unable to be definitively determined.The distal femur axial pin was found to have been manufactured without issue and was conforming during all inspection.The tibial hinge component and the distal femur implant were also found to not have any issues during manufacturing and were also conforming during all inspection.There was no report that the surgeon deviated from the recommended surgical technique.However, based on review of the device history records and sterilization batch release records, it was concluded that the failure was not associated with the manufacture or the sterilization of the implants or a nonconformance.
Event or Problem Description
A patient was undergoing a surgery on (b)(6) 2021 performed by dr.(b)(6) to place a distal femur implant.When the surgeon attempted to place a distal femur axial pin to join the distal femur implant and the tibial hinge component, the poly component of the distal femur axial pin broke off of the implant.This led to a short delay in surgery of less than fifteen minutes while a replacement distal femur axial pin was retrieved and implanted.

• Brand Name: ELEOS
• Common Device Name: TIBIAL HINGE COMPONENT, W/O STOP
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• MDR Report Key: 11711727
• Report Number: 3013450937-2021-00052
• Device Sequence Number: 3659901
• Product Code: KRO
• UDI-Device Identifier: B27825002101E0
• UDI-Public: B27825002101E0
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K161520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 25002101E
• Device Catalogue Number: 25002101E
• Device Lot Number: 1825930
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2021
• Initial Report FDA Received Date: 04/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR