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

Model Number	V0200023
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	12/17/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a tka procedure, while placing femur block on, distal resection was very off.It seemed like it made the anterior cut in 20 degrees of flexion.Switched to standard instrumentation to complete the procedure.Surgery was prolonged.No impact or injury to patient reported.
Additional Manufacturer Narrative
It was reported that during a tka procedure, while placing femur block on, distal resection was very off.It seemed like it made the anterior cut in 20 degrees of flexion.The affected visionaire cutting block kit, 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.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Our investigation including an engineering review by our visionaire team noted that after evaluation, it was found that the anterior of the femur was over segmented which could have cause misplacement of the cutting guide causing the observed complaint.A relationship, if any, between the device and the reported incident is corroborated.Incorrect segmentation is probably the root cause of the reported event.Based on this investigation, the corrective action has been implemented.The alignment engineer has 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.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, the complaint will be reopened.We consider this investigation closed.

• Brand Name: NON STRL VISIONAIRE RT CUT BLK 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: 9598308
• Report Number: 1020279-2020-00297
• Device Sequence Number: 3175541
• Product Code: JWH
• UDI-Device Identifier: 00885556583074
• UDI-Public: 00885556583074
• 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): 09/08/2020

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: V0200023
• Device Catalogue Number: V0200023
• Device Lot Number: 00160181
• Initial Date Received by Manufacturer: 12/17/2019
• Supplement Date Received by Manufacturer: 08/31/2020
• Initial Report FDA Received Date: 01/16/2020
• Supplement Report FDA Received Date: 09/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1