MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; CEMENTED SEGMENTAL STEM, 9X100MM, STRAIGHT, FLUTED

Model Number	CS-09100-03M
Medical Device Problem Code	Device Damaged Prior to Receipt by User (1570)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2023
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 trays of the cemented straight segmental stem packaging were no longer sealed.Upon opening the box, this malfunction was identified and the device was not used.The surgeon implanted a different segmental stem.No additional information regarding this malfunction has been reported.
Event or Problem Description
It was reported that during a surgery on (b)(6) 2023, it was identified that the inner and outer trays of the cemented straight segmental stem packaging were no longer sealed.Upon opening the box, this malfunction was identified and the device was not used.The surgeon implanted a different segmental stem.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 root cause of the broken sterile barrier could not be determined.The device was visually inspected and it was evident that there was sealant residue on both the inner tray and outer tray and tray lids indicating that the trays had both been sealed properly during packaging.The device history records and sterilization batch records were reviewed and no issues during manufacturing or sterilization were identified that would have contributed to this complaint.If any additional information is obtained, a supplemental mdr will be filed accordingly.The following sections were updated: b4: date of this report added g3: date received by manufacturer added g6: type of report added h2: follow-up type added 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 10: testing of actual/suspected device h6: type of investigation code updated to 4109: historical data analysis h6: investigation findings code updated to 171: packaging compromised h6: investigation conclusions code updated to 4315: cause not established h10: additional narratives/data.

• Brand Name: ELEOS
• Common Device Name: CEMENTED SEGMENTAL STEM, 9X100MM, STRAIGHT, FLUTED
• 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: 16945615
• Report Number: 3013450937-2023-00077
• Device Sequence Number: 6555027
• Product Code: KRO
• UDI-Device Identifier: B278CS0910003M0
• UDI-Public: B278CS0910003M0
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 07/17/2023

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 Expiration Date: 01/18/2024
• Device Model Number: CS-09100-03M
• Device Catalogue Number: CS-09100-03M
• Device Lot Number: 81676
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2023
• Supplement Date Received by Manufacturer: 07/17/2023
• Initial Report FDA Received Date: 05/17/2023
• Supplement Report FDA Received Date: 07/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2019
• 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: 12 YR
• Patient Sex: Female