MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; TIBIAL BASEPLATE, SIZE 3

Model Number	TB-2203E-01M
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is in process.When the investigation is complete, a supplemental mdr will be submitted accordingly.
Event or Problem Description
It was reported that during a surgery on (b)(6) 2023, it was identified that the inner and outer tyvek seals of the size 3 tibial baseplate packaging were not attached to the corresponding trays.Upon opening the box, this malfunction was identified and the device was not used in the procedure.The surgeon implanted a different size 3 tibial baseplate.No additional information regarding this malfunction has been reported.
Additional Manufacturer Narrative
This report is being submitted to include additional information.The investigation is complete.The device was returned for evaluation.The device was evaluated and it was determined that there was sealant reside on the lips of the trays indicating that the trays had been properly sealed during packaging.The device history records and sterilization batch records were reviewed and there were no non-conformances identified that would have contributed to this complaint.The root cause of this complaint was determined to be a user error in the field.The device was opened by a representative in a previous surgery and was not disposed of properly.This issue is an isolated incident that is not related to the design, manufacturing or packaging of the part.If additional information is obtained, a supplemental mdr will be filed accordingly.The following sections were updated: h3: device evaluated by manufacturer updated to yes.H6: type of investigation code updated to 3331: analysis of production records.H6: type of investigation code updated to 4110: trend analysis.H6: type of investigation code updated to 4109: historical data analysis.H6: type of investigation code updated to 10: testing of actual/suspected device.H6: investigation findings code updated to 4248: usage problem identified.H6: investigation conclusions code updated to 19: cause traced to user.
Event or Problem Description
It was reported that during a surgery on (b)(6) 2023, it was identified that the inner and outer tyvek seals of the size 3 tibial baseplate packaging were not attached to the corresponding trays.Upon opening the box, this malfunction was identified and the device was not used in the procedure.The surgeon implanted a different size 3 tibial baseplate.No additional information regarding this malfunction has been reported.

• Brand Name: ELEOS
• Common Device Name: TIBIAL BASEPLATE, SIZE 3
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• Manufacturer (Section G): PHILLIPS PRECISION INC; 7 paul kohner pl; elmwood park NJ 07407
• Manufacturer Contact: sara dailey ; 77 east halsey road; parsippany, NJ 07054 ; 8447672766
• MDR Report Key: 17194872
• Report Number: 3013450937-2023-00113
• Device Sequence Number: 7461887
• Product Code: KRO
• UDI-Device Identifier: B278TB2203E01M0
• UDI-Public: B278TB2203E01M0
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K161520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: TB-2203E-01M
• Device Catalogue Number: TB-2203E-01M
• Device Lot Number: 95375-020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2023
• Supplement Date Received by Manufacturer: 08/24/2023
• Initial Report FDA Received Date: 06/23/2023
• Supplement Report FDA Received Date: 08/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/13/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Female