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

Model Number	V0200106
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a tka, one (1) ns vis adpt guide gii kit did not fit properly and produced insufficient distal femoral resection.The procedure was completed using intramedullary instrumentation and it is unknown if there was any delay.Unplanned extra distal femoral bone needed to be resected, as well as introducing intramedullary instruments up the femoral canal.
Additional Manufacturer Narrative
Internal complaint reference: case (b)(4).
Additional Manufacturer Narrative
H3, h6: 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.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.As visionaire devices are custom made devices, a review of the complaint history for this part is not applicable.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.At this time, we have no reason to suspect 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, user/procedural variance or segmentation error.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.H1.

• Brand Name: NS VIS ADPT GUIDE GII 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: 16668683
• Report Number: 1020279-2023-00752
• Device Sequence Number: 12408832
• Product Code: JWH
• UDI-Device Identifier: 00885556656532
• UDI-Public: 00885556656532
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2023

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: 07/19/2023
• Device Model Number: V0200106
• Device Catalogue Number: V0200106
• Device Lot Number: 00251929V1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2023
• Supplement Date Received by Manufacturer: 07/19/2023
• Initial Report FDA Received Date: 04/03/2023
• Supplement Report FDA Received Date: 07/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/20/2023
• 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: Unknown