MAUDE Adverse Event Report: SMITH & NEPHEW, INC. VISIONAIRE LT CUTTING BLOCK KIT - LGNP; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	V0100022
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/11/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a malfunction occurred during surgery.The cutting slot of the femur block was not completely molded so the surgeon ended up physically cutting through the femur block.Standard distal femoral cutting block used.No impact to the patient occurred.The patient still experienced a successful total knee replacement.
Additional Manufacturer Narrative
The associated legion visionaire cutting block kit was not returned for evaluation.Therefore a product evaluation could not be performed.However, case details have been provided.Therefore, an evaluation was conducted based on the information received.The review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.Our investigation including an engineering evaluation by our visionaire team noted that after evaluation, no root cause could be found for the complaint.All parts of the design were within visionaire standards.The part passed gauge inspection for anterior pinholes before shipping.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: VISIONAIRE LT CUTTING BLOCK KIT - LGNP
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8040447
• Report Number: 1020279-2018-02379
• Device Sequence Number: 11128819
• Product Code: JWH
• UDI-Device Identifier: 03596010653130
• UDI-Public: 03596010653130
• 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: consumer,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/22/2018
• Device Catalogue Number: V0100022
• Device Lot Number: 00119394V1
• Initial Date Received by Manufacturer: 10/14/2018
• Supplement Date Received by Manufacturer: 10/14/2018
• Initial Report FDA Received Date: 11/05/2018
• Supplement Report FDA Received Date: 05/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1