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

Catalog Number	V0200112
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10.Internal reference number: (b)(4).H3, h6: the associated device was returned and evaluated.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.The visual inspection did not reveal any defects.However, a review made by the quality engineering team revealed that during the investigation, it was found that 2 case projects had the same patient's last name associated with them and were mixed.Further investigation revealed that the parts went through the clean process at the same time and swapped when paired back together with the representation orders.A review of complaint history for the previous 12 months did not reveal similar events for the listed device.A historical review concluded that there are no prior actions related to this product and event.According to inspection drawings, the patient name/identifier and lot number on part should be verified to match the print.At this time, we do have evidence to conclude that the product failed to meet specifications at the time of manufacture.The root cause of this event was determined to be a swap between the devices after the cleaning process.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.
Event or Problem Description
It was reported that during set up or inspection for tka case was sent another patient instrument with the same last name.The block received was for the wrong patient.The outer box, label and stickers were correct.Upon opening the inner sterile packaging, it was discovered the vis adpt guide kit jii block was incorrect.The procedure was completed after a significant delay greater than 30mins with manual standard instrumentation and did not use the block.No injury was reported as a consequence of this issue.

• 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: 20558668
• Report Number: 1020279-2024-02235
• Device Sequence Number: 12978239
• Product Code: JWH
• UDI-Device Identifier: 00885556658406
• UDI-Public: 885556658406
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K170282
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/29/2024

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: 03/20/2024
• Device Catalogue Number: V0200112
• Device Lot Number: 00269417V1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2023
• Initial Report FDA Received Date: 10/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: V0200112 / LOT NUMBER: 00269417V2
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female