MAUDE Adverse Event Report: SMITH & NEPHEW, INC. NS VIS CUT GUIDE LGNP KIT RT; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Model Number	V0200023
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/06/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during total knee arthroplasty the femur block fit perfectly, surgeon pinned and cut, after cutting the posterior resection of the femur the surgeon noticed that the posterior cuts were off, they measured the resection and they turned out to be 16 mm medial and 5 mm lateral.Doctor held the femur guide up to the femur bone and said that the pin holes he used matched up to the guide.There was a delay of 15 minutes.
Additional Manufacturer Narrative
The device, used in treatment, was returned for evaluation.The engineering evaluation confirmed that areas of the distal femur were undersegmented but would have had little to no impact on block fit and posterior resections.It was also determined that file transfer issues caused an incorrect pre-op plan but the blocks were created based on the correctly aligned bone models, so this would not have had an impact on the complaint issue.Therefore, no root cause could be determined.A medical investigation was conducted and confirms based on the information provided, the clinical root cause of the reported event could not be definitively concluded.The product/engineering evaluation results were not available at the time of this assessment.The known patient impact is related to the reported 0-30 minute surgical extension and additional soft tissue releases to balance the knee but future impact is unknown.No further medical assessment can be rendered at this time.The product/engineering evaluation remains pending at this time; however, should the product/engineering evaluation reveal pertinent findings and/or the requested clinical documentation becomes available in the future, the clinical/medical task may be re-evaluated.No complaint history for this part as this is a patient-specific device.Dhr review yields that all appropriate manufacturing and inspection steps took place.No root cause for complaint description can be determined by dhr.A review of risk management files and instructions for use found that the reported failure was documented appropriately.Possible probable cause could include but not limited the user error.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: NS VIS CUT GUIDE LGNP KIT RT
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10780126
• Report Number: 1020279-2020-06076
• Device Sequence Number: 3772991
• Product Code: JWH
• UDI-Device Identifier: 00885556583074
• UDI-Public: 00885556583074
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 09/23/2021

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 Model Number: V0200023
• Device Catalogue Number: V0200023
• Device Lot Number: 00182275V1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2020
• Initial Date Received by Manufacturer: 10/06/2020
• Supplement Date Received by Manufacturer: 09/22/2021
• Initial Report FDA Received Date: 11/03/2020
• Supplement Report FDA Received Date: 09/23/2021
• 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: Hospitalization; Required Intervention