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

Model Number V0100112

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/25/2022

Event Type  Injury  

Event Description

It was reported that, during a tka surgery, the tibial cutting block from the (b)(6) kit jii was in valgus.The extra-medullary guide had to be used to proceed.It is unknown if surgery was delayed and if patient was harmed as consequence of this problem.

Manufacturer Narrative

Internal complaint reference: (b)(4).

Manufacturer Narrative

H3, h6: the device was not returned for evaluation.This event was evaluated by our quality engineering team, and concluded that could not confirm a root cause for the stated failure mode.All checks were found to be within visionaire standards.The clinical/medical investigation concluded that, per complaint details, ¿the tibial cutting block was in valgus again, had to use extra-medullary guide¿ to proceed.Responses to the information requests had not been received as of the date of this medical investigation.It is unknown if there was a procedural delay or further patient impact; however, no patient injury was reported.Without the requested clinical information, the root cause could not be definitively concluded and the patient impact beyond the reported change in surgical technique could not be determined.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 the instructions for use documents for visionaire¿ patient matched instrumentation with fastpak instruments revealed that if the patient matched cutting guide does not perform as intended, standard smith & nephew instrumentation should be used 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.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors that could contribute to the reported event include surgical technique used, user/procedural variance or segmentation error.The contribution of the device to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.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: VIS ADPT GUIDE KIT JII
• 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: 13510645
• MDR Text Key: 285774046
• Report Number: 1020279-2022-00651
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00885556656419
• UDI-Public: 00885556656419
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/20/2022
• Device Model Number: V0100112
• Device Catalogue Number: V0100112
• Device Lot Number: 00217651V1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/21/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/22/2021
• 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): Required Intervention
• Patient Sex: Male