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

Model Number 25002101E

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 03/25/2021

Event Type  malfunction  

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 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
• Type of Device: TIBIAL HINGE COMPONENT, W/O STOP
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• Manufacturer (Section G): MICROPORT ORTHOPEDICS; 5677 airline road; arlington TN 38002
• Manufacturer Contact: jonathan zachok ; 77 east halsey road; parsippany, NJ 07054
• MDR Report Key: 11711727
• MDR Text Key: 249248747
• Report Number: 3013450937-2021-00052
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: B27825002101E0
• UDI-Public: B27825002101E0
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161520
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 25002101E
• Device Catalogue Number: 25002101E
• Device Lot Number: 1825930
• Date Manufacturer Received: 03/25/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR