MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; TIBIAL BASEPLATE, SIZE 4

Model Number	TB-2204E-01M
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The root cause for the complaint was unable to be definitively determined.The sales representative reported that there was no poly taper plug present when the packaging of the tibial baseplate.However, the dhr shows that the plug was assigned as a subcomponent and the other part of the lot was pulled from finished goods and the plug was present.There have been no other complaints of the poly taper plug being missing.The poly taper plug is used infrequently as the tibial baseplate is often used with a stem extension.However, prior to the design change to add the screw hole, even if no stem extension or poly taper plug were used, no cement would be able to extrude out through the implant as there was no through hole.Now that there is a screw hole in the implant, it is necessary to utilize the poly taper plug when no stem extension is used.The root cause analysis conducted as part of (b)(4) found the following root causes to the issue: the surgical technique did not provide guidance or emphasize the necessity with the new design to use the taper plug when there is no stem extension.The field did not know the necessity to use the taper plug with the new design.
Event or Problem Description
A patient was undergoing a surgery on (b)(6) 2021 performed by dr.(b)(6) when the surgeon placed a tibial baseplate without a stem extension.While cementing the tibial baseplate into the patient's tibia, cement started to extrude through the screw hole and out of the top of the implant.The surgeon removed the tibial baseplate intraoperatively and cleaned away the cement.The tibial baseplate is packaged with a taper poly plug which can be optionally used if a stem extension is not being implant.However, the sales representative stated that there was no plug packaged with the implant.The surgeon was able to plug the tibial baseplate with a metal plug and implanted the tibial baseplate successfully.The intraoperative issue led to a delay in surgery of between 10 and 40 minutes.

• Brand Name: ELEOS
• Common Device Name: TIBIAL BASEPLATE, SIZE 4
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• MDR Report Key: 12442386
• Report Number: 3013450937-2021-00195
• Device Sequence Number: 17432293
• Product Code: KRO
• UDI-Device Identifier: B278TB2204E01M0
• UDI-Public: B278TB2204E01M0
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K203588
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/08/2021

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: TB-2204E-01M
• Device Catalogue Number: TB-2204E-01M
• Device Lot Number: 90126
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2021
• Initial Report FDA Received Date: 09/08/2021
• 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: 64 YR