MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; CEMENTED SEGMENTAL STEM, 13X120MM, STRAIGHT, FLUTED

Model Number CS-13120-03M

Device Problem Shipping Damage or Problem (1570)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/25/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation is in process.When the investigation is complete, a supplemental mdr will be submitted accordingly.

Event Description

It was reported that during a surgery on (b)(6) 2022, it was identified that the packaging of the cemented segmental stem was damaged and 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.

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: 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 4111: communication/interviews.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.

Event Description

It was reported that during a surgery on (b)(6) 2022, it was identified that the packaging of the cemented segmental stem was 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.

• Brand Name: ELEOS
• Type of Device: CEMENTED SEGMENTAL STEM, 13X120MM, 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
• MDR Report Key: 15851572
• MDR Text Key: 304882459
• Report Number: 3013450937-2022-00346
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: B278CS1312003M0
• UDI-Public: B278CS1312003M0
• 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: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: CS-13120-03M
• Device Catalogue Number: CS-13120-03M
• Device Lot Number: 91399-009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/2021
• 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 Age: 70 YR
• Patient Sex: Male