MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; BIOGRIP PROXIMAL TIBIA

Model Number	PT-20000-02M
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The root cause for the intraoperative issues was determined to be that the edges of the suture holes were too sharp for the sutures and caused them to rupture when the surgeon pulled against them with too much force.This issue was due to the design of the components as the specification for the implant was ambiguous and did not specify how rounded the edges of the suture holes should be.The manufacturing of the implant was not a contributing factor as the implants were within the given design specification.The root cause of this issue was further investigated in a capa.
Event or Problem Description
A patient underwent a surgery on (b)(6) 2021 performed by dr.Fabbri to place eleos components for a patient who had the proximal end of his tibia resected.A proximal tibia implant was placed during the surgery.When the surgeon attempted to place sutures through the suture holes of the implant for fixation of soft tissue, the edges of the suture holes of the implant were causing the sutures to rupture when the surgeon tightened them to tie the ends together.The surgeon first used a ethibond 5/0 suture, but they ruptured.The surgeon then switched to a ethibond 1 suture, but they also ruptured.The surgeon wrapped the sutures around and tied the ends together on the posterior side of the implant.This allowed for the sutures to not be pulled back against the sharp edge of the suture holes on the implant.The sales representative stated that the sutures rupturing added approximately 20 minutes to the surgery time.He also stated that the surgeon determined that tying the sutures behind the implant would be sufficient for the patient and that no revision surgery would be required at this time.

• Brand Name: ELEOS
• Common Device Name: BIOGRIP PROXIMAL TIBIA
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• MDR Report Key: 11396800
• Report Number: 3013450937-2021-00014
• Device Sequence Number: 19713776
• Product Code: KRO
• UDI-Device Identifier: B278PT2000002M0
• UDI-Public: B278PT2000002M0
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K161520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: PT-20000-02M
• Device Catalogue Number: PT-20000-02M
• Device Lot Number: 88658
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2021
• Initial Report FDA Received Date: 03/01/2021
• 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: 61 YR