MAUDE Adverse Event Report: ONKOS SURGICAL INC. ELEOS; HYBRID CEMENTED SEGMENTAL STEM, 13MM X 120MM, STRAIGHT, FLUTED

Model Number HC-13120-03M

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

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

Event Date 04/25/2022

Event Type  malfunction  

Event Description

It was reported that during an eleos proximal femoral replacement surgery on (b)(6) 2022, the surgeon implanted the eleos modular collar cemented stem without a eleos modular collar or eleos collar locking ring.This type of stem is intended to be implanted with a modular collar and collar locking ring.No adverse events have been reported from this malfunction.This event will be reportable to the fda as a malfunction.

Manufacturer Narrative

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

Manufacturer Narrative

It was reported that during an eleos proximal femoral replacement surgery on 2(b)(6) 2022, the surgeon implanted the eleos modular collar cemented stem without a eleos modular collar or eleos collar locking ring.This type of stem is intended to be implanted with a modular collar and collar locking ring.No adverse events have been reported from this malfunction.Based upon the device history records, sterilization records, and interview with the sales representative the investigation suggests that the root causes of the issue is not likely to be related to the manufacture, and/or sterilization of the component.The surgical technique specifies the eleos modular collar cemented stem to be implanted with the eleos modular collar and eleos collar locking ring.The surgical technique for the eleos proximal femoral replacement (elss pf 06.09.21 v4) was reviewed and the following applicable excerpts were found: modular collar and stem implant assembly: o assemble the collar over the intermedullary shaft of the hybrid stem, starting distally and sliding up the stem proximally.Confirm the taper of the collar threads matches the taper of the stem shaft.O assemble the locking ring over the proximal end of the hybrid stem in preparation for threading to the collar.O hand-tighten the locking ring while holding the collar in a firm fingertip grip.O insert the counter-torque socket into the assembly tower base hole.O align the t-shaped anti-rotation boss of the stem with the matching t-slot of the countertorque socket.Insert the hand-tightened stem collar-locking ring assembly into the countertorque socket.O slide the open socket of the torque wrench on the hex of the locking ring ensuring the handle of the torque wrench is fully seated.O insert the counter-torque handle into the indicated hole of the counter-torque socket facing the user.O in a scissor motion, apply force on the torque wrench handle in the direction of the "tightening" arrow on the upper surface of the counter-torque socket until the handle shaft reaches a minimum of 35nm on the torque wrench scale indicator.O remove the torque wrench and stem-collar locking ring assembly from the socket.O rotate the stem-collar locking ring assembly until the locking ring impactor hole is aligned vertically up.O insert the stem-collar-locking ring assembly in the hex socket of the counter-torque socket, ensuring the peening hole is visible through the guide ring of the counter-torque socket.O thread a single-use impactor tip on the collar impactor.O insert the impactor tip into the guide ring of the counter-torque socket, ensuring that the black ring on the tip is no longer visible (it is covered by the guide ring).O while firmly holding the collar impactor, firmly strike the impactor with the surgical mallet five times.O remove the stem-collar-locking ring assembly from the hex socket of the counter-torque socket.Proceed to the standard surgical technique step for standard impaction to the implant and/or optional midsections the root cause of this issue was not able to be determined conclusively.

• Brand Name: ELEOS
• Type of Device: HYBRID CEMENTED SEGMENTAL STEM, 13MM X 120MM, STRAIGHT, FLUTED
• Manufacturer (Section D): ONKOS SURGICAL INC.; 77 e halsey road; parsippany NJ 07054
• Manufacturer Contact: upasana basnet ; 77 e halsey rd; parsippany, NJ 07054
• MDR Report Key: 16497048
• MDR Text Key: 310824016
• Report Number: 3013450937-2023-00041
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: B278HC1312003M0
• UDI-Public: B278HC1312003M0
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K203815
• 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: 06/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HC-13120-03M
• Device Catalogue Number: HC-13120-03M
• Device Lot Number: 84549-012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/25/2021
• 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 Outcome(s): Other
• Patient Age: 67 YR
• Patient Sex: Female