MAUDE Adverse Event Report: SMITH & NEPHEW, INC. VIS CUT GUIDE LGNP FEM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/

Model Number	V0100020
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference number: (b)(4).
Event or Problem Description
It was reported that, during a tka procedure, the femur block didn¿t fit and the surgeon had to convert to standard instruments.According to the sales rep, when dr.(b)(6)pushed down the distal medial paddle, it came off distal lateral bone and vice versa.He also said the block "didn¿t have the typical hook feel".Instruments were inside the patient.It is unknown if there was a delay.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The associated device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The engineering evaluation could not confirm the stated failure mode.The evaluation determined that all parts of the design were within visionaire standards.No root cause could be found for the complaint.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.Some potential probable causes for this event could include surgical technique or a procedural variance.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.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.

• Brand Name: VIS CUT GUIDE LGNP FEM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11391116
• Report Number: 1020279-2021-01684
• Device Sequence Number: 16464585
• Product Code: JWH
• UDI-Device Identifier: 00885556076958
• UDI-Public: 00885556076958
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K082358
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: V0100020
• Device Catalogue Number: V0100020
• Device Lot Number: 00187693V1
• Initial Date Received by Manufacturer: 02/04/2021
• Supplement Date Received by Manufacturer: 10/05/2021
• Initial Report FDA Received Date: 03/01/2021
• Supplement Report FDA Received Date: 10/06/2021
• 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: Other; Required Intervention