MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; DISTAL FEMUR AXIAL PIN, ONE SIZE

Model Number 25002111E

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 dr.(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.

Event Description

A patient was undergoing a surgery on (b)(6) 2021 performed by dr.(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.

Manufacturer Narrative

The raw material dhr for the poly subcomponents that were damaged was reviewed.The material met all required material specifications.There was no indication that the material contributed to this complaint.

• Brand Name: ELEOS
• Type of Device: DISTAL FEMUR AXIAL PIN, ONE SIZE
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• MDR Report Key: 11837662
• MDR Text Key: 262229727
• Report Number: 3013450937-2021-00079
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: B27825002111E0
• UDI-Public: B27825002111E0
• Combination Product (y/n): N
• PMA/PMN Number: K161520
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 06/18/2021

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: 25002111E
• Device Catalogue Number: 25002111E
• Device Lot Number: 1849157
• Date Manufacturer Received: 04/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 88 YR