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 Inadequacy of Device Shape and/or Size (1583)

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

Event Date 11/08/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that, during a tka surgery, while using the vis adpt guide kit jii, the femoral block was a poor fit.The patient's trochlear groove was not a good match with the block, the patient's anatomy was shallow compared to the cutting block.The doctor chose to remove a few osteophytes in order to try to get a better fit, but there was a significant anterior gap.Surgeon used the alignment guide and drop rod to confirm alignment was adequate.Surgeon made the visionaire guided femur cut, then took a +2mm distal recut.The anterior cut and rotation were adequate for the 5-in-1 cut.The procedure was resumed, after a non-significant delay, with the same device.Patient was not harmed as consequence of this problem.

Manufacturer Narrative

H3, h6: the device was not returned for evaluation.However, a review made by the quality engineering team revealed that after evaluation, it was found that the femur was segmented inconsistently, with both oversegmentation and undersegmentation present.The clinical/medical investigation concluded that, per complaint details, the femoral block was a poor fit; therefore the surgeon chose to remove a few osteophytes in order to try to get a better fit, but there was a significant anterior gap which required an additional +2mm distal recut.Reportedly, the anterior cut and rotation were adequate for the 5-in-1 cut and the procedure was resumed after a non-significant delay with the same device without patient harm.The visionaire surgical technique, does recommend use of back-up instrumentation, if the adaptive guide be determined unsuitable for its intended use.As of the date of this medical investigation, the requested clinical documentation has not been received.Based on the limited information provided, there were no definitive clinical factors found that would have contributed to the reported event.Further patient impact would not be anticipated as the surgeon reportedly completed the procedure with the same device within a 0-30 minute surgical extension with a change of surgical technique and no patient injury was alleged.Based on this information, no further medical assessment is warranted at this time.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 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 to the inspection drawing, part number, size, recut type, blade thickness and part configuration should be verified, it also has to be verified that the part should be free of burrs, damaged areas and sharp edges, besides dimensions should be measured with caliper to ensure print specifications.At this time, we do have reason to suspect that the product failed to meet specifications at the time of manufacture.The root cause of this event was determined to be inconsistent femur segmentation, with both oversegmentation and undersegmentation present.Based on this investigation, the need for corrective action is not indicated.Should 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: 15923610
• MDR Text Key: 304878894
• Report Number: 1020279-2022-04899
• 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: 03/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/26/2023
• Device Model Number: V0100112
• Device Catalogue Number: V0100112
• Device Lot Number: 00243162V1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2022
• 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