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 06/30/2020

Event Type  malfunction  

Manufacturer Narrative

The device history record was reviewed and did not indicate any nonconformances 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 sales representative flagged a reusable instrument due to a missing poly subcomponent.

• Brand Name: ELEOS STEM IMPACTOR
• Type of Device: INSTRUMENT, KNEE
• Manufacturer (Section D): ONKOS SURGICAL; 77 e halsey road; parsippany, nj
• Manufacturer (Section G): PHILLIPS PRECISION INC.; 7 paul kohner place; elmwood park, nj
• Manufacturer Contact: cristina butrico ; 77 e halsey road; parsippany, nj
• MDR Report Key: 10349783
• MDR Text Key: 201883014
• Report Number: 3013450937-2020-00116
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: B278SI7501E03N0
• UDI-Public: B278SI7501E03N0
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161520
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/30/2020

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
• 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: 07/16/2020
• Initial Date Manufacturer Received: 06/30/2020
• Initial Date FDA Received: 07/31/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/06/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other