MAUDE Adverse Event Report: ONKOS SURGICAL RESURFACING FEMUR AXIAL PIN; PROSTHESIS, KNEE

Catalog Number	25002112E
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is for one of two devices involved in this event, please refer to report 3013450937-2019-00023.The device history record and sterilization batch release record were reviewed and found that the design manufacturing and sterilization did not lead to this complaint.The component was disposed of and was unable to be further investigated.Should additional information be obtained the report will be supplemented.
Event or Problem Description
An eleos resurfacing femur limb salvage system was implanted and while assembling the components, the threads of the axial pin inserter/extractor fractured off within the resurfacing femur axial pin.The resurfacing femur axial pin was removed, and a new pin was placed.
Event or Problem Description
An eleos resurfacing femur limb salvage system was implanted and while assembling the components, the threads of the axial pin inserter/extractor fractured off within the resurfacing femur axial pin.The resurfacing femur axial pin was removed, and a new pin was placed.
Additional Manufacturer Narrative
This report is for one of two devices involved in this event, please refer to report 3013450937-2019-00023.The device history record and sterilization batch release record were reviewed and found that the design manufacturing and sterilization did not lead to this complaint.The component was disposed of and was unable to be further investigated.Should additional information be obtained the report will be supplemented.

• Brand Name: RESURFACING FEMUR AXIAL PIN
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• MDR Report Key: 8688677
• Report Number: 3013450937-2019-00022
• Device Sequence Number: 19426282
• Product Code: KRO
• UDI-Device Identifier: B27825002112E0
• UDI-Public: B27825002112E0
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K161520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/16/2026
• Device Catalogue Number: 25002112E
• Device Lot Number: 1764143
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/14/2019
• Supplement Date Received by Manufacturer: 05/14/2019
• Initial Report FDA Received Date: 06/11/2019
• Supplement Report FDA Received Date: 12/06/2019
• 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: 68 YR