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 Laceration(s) (1946)

Event Date 02/02/2024

Event Type  Injury  

Manufacturer Narrative

Internal reference number: (b)(4).H10: smith & nephew is submitting this report pursuant to the provisions of 21 c.F.R.Part 803.This report may be based upon information which smith & nephew has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, or its employees, that the report constitutes an admission that the device, smith & nephew or its employees caused or contributed to the potential event described in this report.

Event Description

It was reported that during tka surgery (b)(4) ns vis adpt guide jii kit size should have been a flexed 5 instead of a 6.With osteophytes removed, the 6 would have overhung the femur by several millimeters.The procedure was resumed, without any delay, using the same device.No other complications were reported.

Manufacturer Narrative

The device was not returned for evaluation; therefore, a device analysis could not be performed.A review made by the quality engineering team revealed that the segmentation was evaluated and found to be within visionaire standards.The clinical/medical investigation concluded that, 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.A user technique/procedural variance cannot be ruled out as a possible contributing factor.The procedure was resumed, without any delay, using the same device and the patient was not affected.No other complications were reported.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history revealed similar events for the part number over the past 12 months.Visionaire devices are patient-matched instruments, therefore, no additional review was performed.This failure mode will be monitored for future complaints for any necessary corrective actions.A review of the instructions for use documents for visionaire revealed in the device description section that if the patient matched cutting guide or fastpack instrument 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 drawing, final inspection includes the verification of part configuration per print.Also the device should be measured with a caliper to ensure the correct size.At this time, we have no evidence to conclude that the product failed to meet any specifications at the time of manufacture.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.

Event Description

It was reported that during tka surgery one (1) ns vis adpt guide jii kit size should have been a flexed 5 instead of a 6.With osteophytes removed, the 6 would have overhung the femur by several millimeters.The size 6 planned cut from the visioniare block was too large.Surgeon downsized to a sz 5 to fit the patients anatomy better.The procedure was resumed, without any delay, using the same device.No other complications were reported.

• 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: 18773273
• MDR Text Key: 336182050
• Report Number: 1020279-2024-00430
• 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,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/27/2024

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: 00276439V1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/02/2024
• Initial Date FDA Received: 02/23/2024
• Supplement Dates Manufacturer Received: 03/13/2024; 03/22/2024
• Supplement Dates FDA Received: 03/15/2024; 03/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2024
• 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