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

Model Number	V0200112
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Perforation (2001); Rupture (2208)
Date of Event	02/09/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: case(b)(4).
Event or Problem Description
It was reported that, during a tka surgery, using a ns vis adpt guide jii kit, the planned femoral component of size 7 overlapped the femoral condylar border both medially and laterally, so that it was necessary to switch to the next smaller size 6.This resulted in an increase in the flexion gap with only minimal correctable anterior incision.To restore a balance between the extension and flexion gaps, the distal femur was resected by 2 mm with the resection block.Consequently, an inlay of 11 mm had to be implanted (originally planned 9 mm + 2 mm resection, given by the smaller femur).The procedure was resumed, after a non-significant delay.Patient current health status is good.
Additional Manufacturer Narrative
Additional information: h6 (component code, type of investigation, investigation findings, investigation conclusions).Results of investigation: the device was not returned for evaluation; therefore, a device analysis could not be performed.A review in the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.However, by means of an engineering evaluation, our team found that the surgeon's preference to downsize the femur component when the patient's case fall into the between size range was not followed during the block design process.As a result of this finding, the staff responsible for this process was notified of the error made in alignment of this case.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the instructions for use documents for visionaire patient matched instrumentation with fastpak instruments revealed that 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 with inspection drawing, part number, size, implant type, hand, recut type, saw blade thickness and part configuration should be verified, besides dimensions should be measured with caliper to ensure print specifications.The clinical/medical investigation concluded that, based on the visionaire post operative case evaluation, incorrect alignment was the root cause to the reported event as the femoral alignment was outside acceptance criteria.Of note, the pre operative plan was auto-approved after the 48-hour review window expired.The patient impact included the reported unplanned (downsized) size 6 femoral component, additional 2mm distal femoral resection, and unplanned (upsized) 11mm thick insert to resolve the flexion gap along with the 10-minute surgical delay.Further impact could not be determined, although a transient rehabilitation phase would be anticipated.At this time, we do have reason to suspect that the product failed to meet specifications at the time of manufacture.Since this failure mode rate is within the anticipated acceptable risk limit, 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.Corrected data: e1, e2 (initial reporter), h6 (health effect - clinical code).

• Brand Name: NS VIS ADPT GUIDE JII KIT
• Common Device Name: 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: 16542387
• Report Number: 1020279-2023-00520
• Device Sequence Number: 6265063
• Product Code: JWH
• UDI-Device Identifier: 00885556658406
• UDI-Public: 00885556658406
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K170282
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/02/2023
• Device Model Number: V0200112
• Device Catalogue Number: V0200112
• Device Lot Number: 00250284V1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2023
• Supplement Date Received by Manufacturer: 09/01/2023
• Initial Report FDA Received Date: 03/14/2023
• Supplement Report FDA Received Date: 09/04/2023
• Date Device Manufactured: 01/03/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female