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	02/12/2021
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.(b)(6) due to an intraoperative issue involving sutures rupturing when being tightened in the anterior posterior suture holes of the biogrip proximal tibia.The surgeon used size 2 and 5 ethibond sutures to fixate soft tissue when placing a gastrocnemius muscle flap over the implant.The sutures ruptured.The surgeon switched to fiberwire which frayed but held the soft tissue.

• Brand Name: ELEOS
• Common Device Name: BIOGRIP PROXIMAL TIBIA
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• MDR Report Key: 11462054
• Report Number: 3013450937-2021-00015
• Device Sequence Number: 19787031
• Product Code: KRO
• UDI-Device Identifier: B278PT2000002M0
• UDI-Public: B278PT2000002M0
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 03/11/2021

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: 02/13/2021
• Initial Report FDA Received Date: 03/11/2021
• 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: 13 YR