MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS QUICK DISCONNECT T-HANDLE; INSTRUMENT, KNEE

Model Number	K0001016E
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the component involved met specification.The sales representative reported that there was no misuse of the instrument.The instrument was returned for further analysis.Should additional information be obtained the report will be supplemented.
Event or Problem Description
A sales representative reported that an instrument failed to mate and became damaged during a surgery.
Event or Problem Description
A sales representative reported that an instrument failed to mate and became damaged during a surgery.
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the component involved met specification.The sales representative reported that there was no misuse of the instrument.The instrument was returned for further analysis.Should additional information be obtained the report will be supplemented.Microport performed a visual inspection on the damaged quick disconnect t-handle and found that the instrument was fractured at the base of both attachment prongs.One of the prongs was completely detached from the body, and the other prong was intact.The fracture propagation was brittle in nature and looked to have been initiated at the base of the prong.With the nature and location of the fracture, it is possible that a torsional load would have resulted in the exhibited failure.This instrument normally goes through torsional motion/forces during reaming and can produce high stresses at the base of the attachment prongs, which can result in a brittle fatigue fracture.Microport performed a dimensional inspection and found that the instrument met specification for all aspects except the characteristics that were affected by the fractured prongs.Ultimately, based upon the device history record, interview with the sales representative, and evaluation of the returned component it was concluded that the instrument failure could not be attributed to the manufacture of the eleos component.

• Brand Name: ELEOS QUICK DISCONNECT T-HANDLE
• Common Device Name: INSTRUMENT, KNEE
• Manufacturer (Section D): ONKOS SURGICAL; 77 e halsey road; parsippany NJ 07054
• MDR Report Key: 10501227
• Report Number: 3013450937-2020-00121
• Device Sequence Number: 19500556
• Product Code: KRO
• UDI-Device Identifier: B278K0001016E0
• UDI-Public: B278K0001016E0
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2020

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: K0001016E
• Device Catalogue Number: K0001016E
• Device Lot Number: CN101369
• Initial Date Received by Manufacturer: 08/09/2020
• Supplement Date Received by Manufacturer: 08/09/2020
• Initial Report FDA Received Date: 09/08/2020
• Supplement Report FDA Received Date: 12/01/2020
• 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: Other