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

Lot Number 1953787

Device Problem Use of Device Problem (1670)

Patient Problem Insufficient Information (4580)

Event Date 09/12/2023

Event Type  malfunction  

Event Description

It was reported that a distal femur axial pin was implanted in a resurfacing femur.

Manufacturer Narrative

The investigation 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 (list out each component): 3013450937-2023-00230.

Manufacturer Narrative

The root cause for the distal femur axial pin was assembled into resurfacing femur was due to use error.The labels of the distal femur axial pin and resurfacing femur were reviewed, and the implants were labeled with the appropriate product description.The surgical technique was also reviewed which included the following verbiage, "the resurfacing axial pin size should match the size of the femoral resurfacing component chosen".During primary surgery, it was reported that a distal femur axial pin was implanted in a resurfacing femur on (b)(6) 2023.This complaint is investigating this intraoperative use error.This is the first complaint received for a distal femur axial pin was assembled into resurfacing femur.All cases that utilized a resurfacing femur were reviewed and this was the first case with this use error.

• Brand Name: ELEOS LIMB SALVAGE SYSTEM
• Type of Device: ELEOS DISTAL FEMUR AXIAL PIN
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsipanny NJ 07054
• Manufacturer (Section G): ONKOS SURGICAL; 77 east halsey road; parsipanny NJ 07054
• Manufacturer Contact: vandita patel ; 77 east halsey road; parsipanny, NJ 07054
• MDR Report Key: 17916843
• MDR Text Key: 325972730
• Report Number: 3013450937-2023-00231
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 1953787
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2023
• 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: 25001040E MALE FEMALE MIDSECTION.; 25001208E TIBIAL POLYSPACER.; CS-13120-03M 13MM X 120MM STRAIGHT FLUTED COLLAR.; KSC16100E 16MM X 100MM STRAIGHT FLUTED.; PT-20000-02M 87MM.; RF-TSCRW-01M RESURFACING FEMUR TAPERED SCREW.; THSMWRS01M TIBIAL HINGE W/ ROTATIONAL STOP.
• Patient Age: 65 YR
• Patient Sex: Female