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

Model Number	SI-7501E-03N
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	08/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record was reviewed and did not indicate any non-conformances that would have led to this malfunction.The instrument was returned for further analysis and this report will be supplemented when further information is made available.
Event or Problem Description
A hospital flagged an instrument, upon initial receipt, due to damages of the poly component.
Event or Problem Description
A hospital flagged an instrument, upon initial receipt, due to damages of the poly component.
Additional Manufacturer Narrative
The device history record was reviewed, and it did not indicate any nonconformances that would have led to this malfunction.The instrument was returned to the contract manufacture and a visual inspection confirmed that the stem impactor insert was damaged with dents and deep gouges in the poly material.Also, a dimensional analysis was performed, on all features able to be measured, which revealed that the instrument met specification.The instrument involved in this complaint is a reusable instrument whose life span depends on the method in which it is used, the duration of use, and its handling between uses.Based upon the device history review and the evaluation of the returned instrument it was concluded that the instrument was manufactured to specification and the stem impactor may have become damaged through increased handling.

• Brand Name: ELEOS STEM IMPACTOR
• Common Device Name: INSTRUMENT, KNEE
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• MDR Report Key: 8959611
• Report Number: 3013450937-2019-00053
• Device Sequence Number: 2563080
• Product Code: KRO
• UDI-Device Identifier: B278SI7501E03N0
• UDI-Public: B278SI7501E03N0
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K161520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2019

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: No Information
• Device Model Number: SI-7501E-03N
• Device Catalogue Number: SI-7501E-03N
• Device Lot Number: 82542
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2019
• Supplement Date Received by Manufacturer: 10/29/2019
• Initial Report FDA Received Date: 09/04/2019
• Supplement Report FDA Received Date: 11/04/2019
• 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