MAUDE Adverse Event Report: SMITH & NEPHEW, INC. VISIONAIRE RT CUTTING BLOCK KIT - LGNP; PRSTHSIS, KEE, PTLLOFEMROTIBIL, SMI-CONSTRIND, CMNTD, PLY/MTL/POLYMR

Model Number	V0100023
Medical Device Problem Code	Failure to Calibrate (2440)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/11/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a right tkr legion visionaire case the tibial block was pinned in place and the cut was made through the block.The gap check was measured and indicated that the space was tight that the surgeon decided to take the additional bone off the tibia.In doing so, the standard metal mis right-sided block was placed over the two pins that remained in the tibia from the visionaire block.The tibial slope from the cut through the visionaire block to the 3-degree right-sided block was noticeably different in regards to slope of the cut vs the cutting block and the resection check through the block.The tibia was re-cut through the standard 3 degree cutting block.Overall alignment of prosthesis was good.

• Brand Name: VISIONAIRE RT CUTTING BLOCK KIT - LGNP
• Common Device Name: PRSTHSIS, KEE, PTLLOFEMROTIBIL, SMI-CONSTRIND, CMNTD, PLY/MTL/POLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9927409
• Report Number: 1020279-2020-01151
• Device Sequence Number: 19537426
• Product Code: JWH
• UDI-Device Identifier: 03596010653147
• UDI-Public: 03596010653147
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2021

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: 02/06/2020
• Device Model Number: V0100023
• Device Catalogue Number: V0100023
• Device Lot Number: 00164549V1
• Initial Date Received by Manufacturer: 03/11/2020
• Supplement Date Received by Manufacturer: 02/24/2021
• Initial Report FDA Received Date: 04/06/2020
• Supplement Report FDA Received Date: 03/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1