MAUDE Adverse Event Report: SMITH & NEPHEW, INC. VISIONAIRE RT CUTTING BLOCK KIT - LGNP; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Model Number	V0100023
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	Injury (2348)
Date of Event	10/23/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a tka procedure, the femur needed to be downsized.It is unknown if there were any delays, but the procedure was successfully completed with an s&n backup device.No patient injuries reported.
Additional Manufacturer Narrative
It was reported that during a tka procedure, the femur needed to be downsized.It is unknown if there were any delays, but the procedure was successfully completed with an sn backup device.The affected visionaire cutting block, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.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 review by our visionaire team noted that after evaluation, it was determined that all alignment parameters were found to be within visionaire standards.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A relationship, if any, between the device and the reported incident could not be corroborated.Ifu review yields that there exists instruction to revert to standard instrumentation if the user observes unsatisfactory performance of device.Risk assessment review noted the failure is appropriately managed by dfmea.No medical records were provided.Without supporting medical documentation, a thorough medical assessment cannot be performed.Some potential cause of the reported event could include but is not limited to the surgical technique used.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however, smith and nephew will continue to monitor for future complaints and investigate as necessary.Should additional information be received, this complaint will be reopened and reevaluated.We consider this investigation closed.

• Brand Name: VISIONAIRE RT CUTTING BLOCK 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: 9337988
• Report Number: 1020279-2019-04067
• Device Sequence Number: 1734947
• Product Code: JWH
• UDI-Device Identifier: 03596010653147
• UDI-Public: 03596010653147
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2020

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: V0100023
• Device Catalogue Number: V0100023
• Device Lot Number: 00155837V1
• Initial Date Received by Manufacturer: 10/23/2019
• Supplement Date Received by Manufacturer: 06/30/2020
• Initial Report FDA Received Date: 11/18/2019
• Supplement Report FDA Received Date: 07/06/2020
• 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: Required Intervention