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

Model Number BP-1417M-03N

Device Problem Naturally Worn (2988)

Patient Problem No Information (3190)

Event Date 08/14/2019

Event Type  malfunction  

Manufacturer Narrative

The device history record was reviewed and indicated that the component involved met specification.The instrument was returned for further analysis and this report will be supplemented when further information is made available.

Event Description

A bowed planer used during a surgery was not properly preparing the bone.The surgeon had to ream up the intramedullary canal and the bowed planer worked better.

Manufacturer Narrative

The device history record was reviewed and indicated that the component involved met specification.Additionally, the instrument was returned, and a visual and dimensional analysis was performed, and it was identified that the instrument was within specification.The instrument initially not functioning as intended could not be attributed to the manufacturing of the component or a nonconformance.Should additional information be obtained the report will be supplemented.

Event Description

A bowed planer used during a surgery was not properly preparing the bone.The surgeon had to ream up the intramedullary canal and the bowed planer worked better.

• Brand Name: ELEOS BOWED STEM PLANER
• Type of Device: INSTRUMENT, KNEE
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• MDR Report Key: 9109770
• MDR Text Key: 159797216
• Report Number: 3013450937-2019-00062
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: B278BP1417M03N0
• UDI-Public: B278BP1417M03N0
• 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: 10/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BP-1417M-03N
• Device Catalogue Number: BP-1417M-03N
• Device Lot Number: SC25836
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2019
• Date Manufacturer Received: 09/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 42 YR