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

Catalog Number	72203523
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/13/2020
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10149278
• Report Number: 1219602-2020-00895
• Device Sequence Number: 13976619
• Product Code: HAB
• UDI-Device Identifier: 00885554027839
• UDI-Public: 885554027839
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/16/2024
• Device Catalogue Number: 72203523
• Device Lot Number: 50845834
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2020
• Initial Date Received by Manufacturer: 05/18/2020
• Supplement Date Received by Manufacturer: 07/01/2020
• Initial Report FDA Received Date: 06/12/2020
• Supplement Report FDA Received Date: 07/08/2020
• 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