MAUDE Adverse Event Report: SMITH & NEPHEW, INC. NON STRL VISIONAIRE LT CUT BLK KIT LGNP; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	V0200022
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/03/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a tka procedure block had a very poor fit.No delay.No revision surgery performed.Procedure was completed with standard instrumentation.No injury or impact to patient reported.
Additional Manufacturer Narrative
The associated visionaire guide kit was returned for evaluation.A visual inspection of the product noted no obvious sign of damage on the part.A review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.Our investigation including an engineering evaluation by our visionaire team noted that after evaluation, it was determined that errors were made during the segmentation of the femur and tibia.These errors would have affected block fit and could have caused the issues described in the complaint.The alignment engineer along with the segmenter have taken steps to ensure that all surgeon preferences are met going forward.At this time we feel these actions will prevent recurrence of this failure.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.Should additional information be received, the complaint will be reopened.

• Brand Name: NON STRL VISIONAIRE LT CUT BLK KIT LGNP
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8476054
• Report Number: 1020279-2019-01335
• Device Sequence Number: 19211354
• Product Code: JWH
• UDI-Device Identifier: 00885556583067
• UDI-Public: 00885556583067
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K082358
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: V0200022
• Device Lot Number: 001295841
• Initial Date Received by Manufacturer: 03/03/2019
• Supplement Date Received by Manufacturer: 03/03/2019
• Initial Report FDA Received Date: 04/02/2019
• Supplement Report FDA Received Date: 06/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1