MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 4.5MM SYNOVATOR PLATINUM SERIES; SAW, POWERED, AND ACCESSORIES

Catalog Number 72203523

Device Problem Fluid/Blood Leak (1250)

Patient Problem Injury (2348)

Event Date 05/13/2020

Event Type  Injury  

Event Description

It was reported that during knee procedure, the synovator platinum blade was not working, a black residue was left behind while using.A backup device was available to complete the procedure with no delay.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10 h3, h6: one 4.5mm synovator platinum series used in treatment was returned for evaluation.Visual assessment confirms the complaint.The information provided states: ¿during knee procedure, the synovator platinum blade was not working, a black residue was left behind while using¿.The device showed flaking.

• Brand Name: 4.5MM SYNOVATOR PLATINUM SERIES
• Type of Device: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10149278
• MDR Text Key: 194985180
• Report Number: 1219602-2020-00895
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 00885554027839
• UDI-Public: 885554027839
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 07/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72203523
• Device Lot Number: 50845834
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2020
• Date Manufacturer Received: 07/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other