MAUDE Adverse Event Report: SMITH & NEPHEW, INC. NS VIS ADPT GUIDE JII KIT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number V0200112

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Perforation (2001)

Event Date 01/22/2024

Event Type  Injury  

Event Description

It was reported that, during a tka surgery, when using a block from a ns vis adpt guide jii kit it made the surgeon cut too much bone on the anterior lateral portion.A different size implant was used than planned.The procedure was resumed, without any delay, using the same kit.No other patient complications were reported.

Manufacturer Narrative

H10: internal complaint reference: (b)(4).

Manufacturer Narrative

The device was not returned for evaluation; therefore, a device analysis could not be performed.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review made by the quality engineering team revealed that the segmentation was evaluated and found to be within visionaire standards.A review of complaint history for the previous 12 months did not reveal similar events for the listed device.As this is an unique batch device, a review of the complaint history for the batch number is not applicable.A review of the instructions for use documents for visionaire¿ patient matched instrumentation with fastpak instruments revealed in warnings that it is the surgeon¿s responsibility to be familiar with the appropriate surgical techniques prior to use of this device.Additionally, if the patient matched cutting block does not perform as intended, use the standard smith & nephew instrumentation to complete the surgery.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.According to the inspection drawings, part number, size, implant type, hand, recut type and sawblade thickness shall be verified.Also, part configuration shall be compared to print.The clinical/medical investigation concluded that, based on the information provided, no clinical factors have been definitively concluded to have contributed to the reported event.It is unknown if the surgical technique and/or instructions for use were adhered to, and a user technique/surgical variance cannot be ruled out as a possible contributing factor.The pre-operative plan x-rays appear to show a slight varus deformity; however, does not provide further insight into the reported event.It was reported that the surgeon was ultimately satisfied with the surgical outcome and does not anticipate further complications due to the reported event.All documents and images provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical/medical investigation.The patient impact included the reported larger than planned anterolateral femoral cuts which required different sized component(s) than originally planned.No delay or patient injury was reported due to this issue.At this time, we have no evidence to conclude that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include surgical technique used or user/procedural variance.Based on this investigation, the need for corrective action is not indicated.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: NS VIS ADPT GUIDE JII KIT
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 18684563
• MDR Text Key: 335113576
• Report Number: 1020279-2024-00340
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00885556658406
• UDI-Public: 885556658406
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170282
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/18/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: V0200112
• Device Lot Number: 00273754V1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/22/2024
• Initial Date FDA Received: 02/12/2024
• Supplement Dates Manufacturer Received: 03/13/2024
• Supplement Dates FDA Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other