MAUDE Adverse Event Report: SMITH & NEPHEW, INC. NS VIS ADPT GUIDE LGNP KIT; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAINED,CEMENTED,POLYMERMETAL

Model Number	V0200109
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a right tka surgery with a patient that requires bi-lateral implantations, a right ns vis adpt guide lgnp kit came with a left femoral guide.The surgeon used the sample visionaire guides provided for the case in order to continue the procedure; however, the sample guides are not intended for use during surgery since they are sold as non-sterile devices.A non-significant delay occurred as a consequence of this incident.Any negative impact on patient has been reported so far.In addition, the south (b)(4) warehouse staff opened the left ns vis adpt guide lgnp kit and confirmed that it includes the right femoral guide.The tka for the left knee is scheduled for (b)(6) 2022.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation.However, an engineering evaluation was performed and determined that the left femoral guide got placed in the kit for the right knee and the right femoral guide got placed in the left knee kit.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.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 do have reason to suspect that the product failed to meet product specifications at the time of manufacture.Manufacturing process errors are likely probable causes of the reported event.The contribution of the device to the reported event could be corroborated since it was determined in the engineering evaluation that the left femoral guide got placed in the kit for the right knee.This issue was identified, a non conformance investigation was performed, quality reviewed the complaint data over the past two years and found no additional complaints for this failure, so it is considered isolated at this time.Since this failure mode rate is within the anticipated acceptable risk limit, no additional actions will be taken at this time.We will continue to monitor complaints for trends and investigate further if needed.Based on this investigation, the need for corrective action is 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: NS VIS ADPT GUIDE LGNP KIT
• Common Device Name: PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAINED,CEMENTED,POLYMERMETAL
• 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: 13026301
• Report Number: 1020279-2021-08715
• Device Sequence Number: 13907385
• Product Code: JWH
• UDI-Device Identifier: 00885556656563
• UDI-Public: 00885556656563
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K170282
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/20/2022
• Device Model Number: V0200109
• Device Catalogue Number: V0200109
• Device Lot Number: 00218587V1
• 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: 11/23/2021
• Supplement Date Received by Manufacturer: 07/29/2022
• Initial Report FDA Received Date: 12/17/2021
• Supplement Report FDA Received Date: 08/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2021
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown