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

Model Number SI-7501E-03N

Device Problem Naturally Worn (2988)

Patient Problem Not Applicable (3189)

Event Date 08/05/2019

Event Type  malfunction  

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 Description

A hospital flagged an instrument, upon initial receipt, due to damages of the poly component.

Event Description

A hospital flagged an instrument, upon initial receipt, due to damages of the poly component.

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
• Type of Device: INSTRUMENT, KNEE
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• MDR Report Key: 8959611
• MDR Text Key: 186209250
• Report Number: 3013450937-2019-00053
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: B278SI7501E03N0
• UDI-Public: B278SI7501E03N0
• Combination Product (y/n): N
• PMA/PMN Number: K161520
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 11/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 10/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other