MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; RESURFACING FEMUR, RIGHT

Model Number 25000009E

Device Problem Fracture (1260)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/19/2021

Event Type  malfunction  

Manufacturer Narrative

The root cause for the intraoperative issues involving two distal femur axial pins being damage while being inserted into the distal femur implant and tibial hinge component.The patient's medical history is unknown.It was reported that the surgeon's technique for inserting the distal femur axial pin was correct.Review of the finished good device dhrs found that all products were conforming and no issues were identified during manufacturing that would have contributed to this complaint.Subcomponents dhrs for the poly components fractured have been requested and when they are received, a supplemental report will be submitted.

Event Description

A patient was undergoing a surgery on (b)(6) 2021 performed by doctor (b)(6) to place eleos components due to resection of a patient's tumor.While attempting final insertion of the axial pin, a small piece of the poly locking ring sheared off.The axial pin was explanted, and a new axial pin as obtained.When attempting final insertion of the new axial pin, the same issue occurred and a small piece of the poly locking ring was sheered off.The surgeon decided to keep this pin inserted in the patient.The issue led to a small delay in surgery which lasted less than 40 minutes.The regional sales manager that was present for the case stated that he did not believe that the surgeon's technique for inserting the axial pin was at fault for the failure.

• Brand Name: ELEOS
• Type of Device: RESURFACING FEMUR, RIGHT
• 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: 11837726
• MDR Text Key: 262234102
• Report Number: 3013450937-2021-00080
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: B27825000009E0
• UDI-Public: B27825000009E0
• 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
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 25000009E
• Device Catalogue Number: 25000009E
• Device Lot Number: 1854208
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/20/2021
• 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: 88 YR