MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS LIMB SALVAGE SYSTEM; ELEOS DISTAL FEMUR AXIAL PIN

Lot Number 1953785

Device Problems Device Appears to Trigger Rejection (1524); Patient-Device Incompatibility (2682)

Event Date 10/05/2023

Event Type  Injury  

Manufacturer Narrative

The investigation is in progress, additional information for this event is not known at this time, if additional information is received, a supplemental report will be submitted accordingly.The following mdrs were submitted for the first revision case: (b)(4).3013450937-2023-00229, 3013450937-2023-00243, 3013450937-2023-00246, 3013450937-2023-00248, 3013450937-2023-00247, 3013450937-2023-00244, 3013450937-2023-00245, 3013450937-2023-00249, and 3013450937-2023-00251.Other mdrs submitted for the 2nd revision case: 3013450937-2023-00250 and 3013450937-2023-00239.Other mdrs submitted for the 3rd revision case: 3013450937-2023-00253.

Event Description

This patient originally received a dfr on (b)(6) 2023 and he presented with symptoms of possible infection.The doctor decided to bring the patient back for a full washout and poly exchange.The first revision was on (b)(6) 2023 (b)(4).The second revision was on (b)(6) 2023 (b)(4).This was the third washout/exchange.

Manufacturer Narrative

Ultimately, the root cause of the patient's infection was unable to be determined.Based upon the device history records, sterilization records, and interview with the sales representative the investigation concluded that the root causes of the alleged infection is not likely due to the design, manufacture, and/or sterilization of the components.The following mdrs were submitted for the first revision case: pcr 09272023-1 3013450937-2023-00229 3013450937-2023-00243 3013450937-2023-00246 3013450937-2023-00248 3013450937-2023-00247 3013450937-2023-00244 3013450937-2023-00245 3013450937-2023-00249 3013450937-2023-00251 other mdrs submitted for the 2nd revision case: 3013450937-2023-00250 3013450937-2023-00239 other mdrs submitted for the 3rd revision case: 3013450937-2023-00252 3013450937-2023-00253.

• Brand Name: ELEOS LIMB SALVAGE SYSTEM
• Type of Device: ELEOS DISTAL FEMUR AXIAL PIN
• Manufacturer (Section D): ONKOS SURGICAL; 77 e. halsey road; parsipanny NJ 07054
• Manufacturer (Section G): ONKOS SURGICAL; 77 e. halsey road; parsipanny NJ 07054
• Manufacturer Contact: vandita patel ; 77 e. halsey road; parsipanny, NJ 07054
• MDR Report Key: 18065842
• MDR Text Key: 327291444
• Report Number: 3013450937-2023-00252
• Device Sequence Number: 1
• Product Code: KRO
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: 1953785
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2023
• 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
• Treatment: 25001208E, TIBIAL 8MM POLY SPACER.; DISTAL FEMUR AXIAL PIN, 25002111E.
• Patient Outcome(s): Required Intervention
• Patient Age: 15 YR
• Patient Sex: Male