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

Catalog Number	V0100023
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/19/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the visionaire blocks did not resect correct cuts according to the plan.The femoral distal medial resection was approximately 1.5, the lateral distal resection was approximately 7mm.The proximal tibial resection according to dr (b)(6) needed and was cut an additional 2mm.The blocks fit well to the bone and appeared to be correctly aligned.The poly selected after all additional resections was a 9mm thickness.
Additional Manufacturer Narrative
The associated visionaire cutting block kit was returned and evaluated.The visual inspection of the returned device shows no obvious damage on the part.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 evaluation by our visionaire team noted that after evaluation, it was determined that the anterior osteophyte on the femur was over-segmented.This was in the block fit area and could have caused the femur block to sit more distally resulting in shallower resection depths than was planned.Additionally, an error occurred during the smoothing process due to over-sanding.This could have further affected the block fit on the anterior of the femur.Consequently, the alignment engineer along with the segmenter have taken steps to ensure that all surgeon preferences are met going forward.At this time we feel these actions will prevent recurrence of this failure.After the execution of this case, it was discovered that there was higher occurrence of over-sanding during the smoothing process due to the use of a new segmentation software.Since then, all employees involved in smoothing have been retrained to avoid the problem in the future.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.Should additional information be received, the complaint will be reopened.

• 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: 8409294
• Report Number: 1020279-2019-01032
• Device Sequence Number: 420889
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2019

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 Catalogue Number: V0100023
• Device Lot Number: 00131481V1
• Initial Date Received by Manufacturer: 02/19/2019
• Supplement Date Received by Manufacturer: 02/19/2019
• Initial Report FDA Received Date: 03/11/2019
• Supplement Report FDA Received Date: 07/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1