MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; STEM IMPACTOR INSTRUMENT

Model Number	SI-7501E-03N
Medical Device Problem Codes	Component Missing (2306); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An instrument was found to be damaged by a sales representative.It is not known if the instrument was involved in a surgery when it was damaged or if it caused an adverse event for a patient.The device has not been returned at this time.A capa has been initiated for this issue.When more information is available, a supplement report will be submitted.
Event or Problem Description
A sales representative found an instrument that was disassembled.It is not known if the damage occured during a surgery or if it negatively affected a patient.If more information is discovered, a supplement report will be submitted.
Additional Manufacturer Narrative
Capa determined that the design of the device was the likely root cause of the failure.A change is in process to correct the issue.
Event or Problem Description
There are still no reported harms to patients that have occured due to this failure.

• Brand Name: ELEOS
• Common Device Name: STEM IMPACTOR INSTRUMENT
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• MDR Report Key: 11671281
• Report Number: 3013450937-2021-00040
• Device Sequence Number: 4268196
• Product Code: KRO
• UDI-Device Identifier: B278SI7501E03N0
• UDI-Public: B278SI7501E03N0
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K161520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SI-7501E-03N
• Device Catalogue Number: SI-7501E-03N
• Device Lot Number: 87424
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2021
• Supplement Date Received by Manufacturer: 03/18/2021
• Initial Report FDA Received Date: 04/15/2021
• Supplement Report FDA Received Date: 06/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1