MAUDE Adverse Event Report: SMITH & NEPHEW, INC. VISIONAIRE LT CUTTING BLOCK KIT-GII; PROSTHSIS,KNEE,PATLLOFEMOROTIBIAL,SMI-CONSTRAIND,CMNTD,POLYMR/MTAL/POLYMR

Catalog Number	V0100012
Medical Device Problem Code	Difficult To Position (1467)
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/28/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the tibial cutting block appeared that is was going to cut in varus.
Additional Manufacturer Narrative
The associated complaint devices were returned and evaluated.A visual examination of the returned cutting blocks indicated no obvious signs of damage.After evaluation, it was determined that metal distortion was present on the mri of the tibia.This distortion was on the anterior of the tibia in the block fit area.This would have affected the fit of the tibia block which could have cause the block to not be properly positioned on the bone.This could have caused the varus alignment seen in the complaint.Corrective actions with be taken in accordance with visionaire standards; evolving the alignment engineer.A clinical analysis indicated that there is no report of patient injury, or surgical delay as a result of this device related issue.All documents and/or images provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical investigation.No further clinical assessment is warranted at this time.If new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: VISIONAIRE LT CUTTING BLOCK KIT-GII
• Common Device Name: PROSTHSIS,KNEE,PATLLOFEMOROTIBIAL,SMI-CONSTRAIND,CMNTD,POLYMR/MTAL/POLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7454991
• Report Number: 1020279-2018-00806
• Device Sequence Number: 1373025
• Product Code: JWH
• UDI-Device Identifier: 03596010653116
• UDI-Public: 03596010653116
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K082358
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/11/2018
• Device Catalogue Number: V0100012
• Device Lot Number: 00107678V1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2018
• Initial Date Received by Manufacturer: 03/28/2018
• Supplement Date Received by Manufacturer: 03/28/2018
• Initial Report FDA Received Date: 04/24/2018
• Supplement Report FDA Received Date: 06/21/2018
• 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
• Patient Age: 52 YR