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

Catalog Number	V0100112
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint number: (b)(4).
Event or Problem Description
It was reported that during a tka surgery, the vis adpt guide kit jii presented an unknown problem.The procedure was resumed after a significant delay and multiple tibial recuts.No further consequences were reported.
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation; therefore, a device analysis could not be performed.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.However, a review made by the quality engineering team revealed that the femur was under segmented which could have caused the block to fit in an unintended position.This is believed to have affected the planned alignment.The manufacturing team was assigned to review the visionaire segmentation work instruction again.Since this failure mode rate is within the anticipated acceptable risk limit in the risk management plan, no additional actions will be taken at this time.A review of complaint history of 12 months revealed similar events for the listed device.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 inspection drawings, part number, size, implant type, hand, recut type and sawblade thickness shall be verified.Also, part configuration shall be compared to print.At this time, we do have evidence to conclude that the product failed to meet 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.

• Brand Name: VIS ADPT GUIDE KIT JII
• 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: 18637603
• Report Number: 1020279-2024-00278
• Device Sequence Number: 7763473
• Product Code: JWH
• UDI-Device Identifier: 00885556656419
• UDI-Public: 00885556656419
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K170282
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 06/01/2024
• Device Catalogue Number: V0100112
• Device Lot Number: 00273331V1
• 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: Not provided
• Supplement Date Received by Manufacturer: 03/06/2024
• Initial Report FDA Received Date: 02/04/2024
• Supplement Report FDA Received Date: 03/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown