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

Model Number	V0200108
Medical Device Problem Codes	Positioning Failure (1158); Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during a tka procedure, it was noticed that when the surgeon placed the ns vis adpt guide lgnp tib on, the alignment drop rod was falling laterally, the slope appeared off from what was planned and the anterior lateral portion of the tibia paddle was not flush.The surgeon removed the block and transitioned to standard instrumentation.His resections measured 7mm lateral, 2.5-3.5mm medial.It is unknown if there was any delay.No further complications reported.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during a tka procedure, it was noticed that when the surgeon placed on the tibial guide of a ns vis adpt guide lgnp kit, the alignment drop rod was falling laterally, the slope appeared off from what was planned and the anterior lateral portion of the tibia paddle was not flush.The surgeon removed the block and transitioned to standard instrumentation.His resections measured ~7mm lateral, ~2.5-3.5mm medial.It is unknown if there was any delay.No further complications reported.
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation but the event could be confirmed with the findings of our internal quality process.An assessment made by a quality engineer was performed and did confirm a potential root cause for the stated failure mode.The evaluation found that the lateral tibia plateau was oversegmented, resulting in the tibia block not sitting flush with the patient's anatomy.This could have also affected the planned coronal alignment and posterior slope indicated by the alignment checker drop rod.The clinical/medical investigation concluded that, based on the imaging provided, the root cause of the reported event could not be definitively concluded.Without the requested clinical information, the patient impact beyond the reported modified surgical procedure could not be determined; however, it was reported that the surgeon transitioned to standardized instrumentation which aligns with the surgical technique.No further medical assessment can be rendered 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, however, at this time, we do have reason to suspect that the product failed to meet product specifications at the time of manufacture.A review of the instructions for use documents for visionaire¿ patient matched instrumentation with fastpak instruments revealed that if the patient matched cutting guide or fastpak instrument does not perform as intended, standard smith & nephew instrumentation should be used to complete the surgery, this has been identified in the device description.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, implant type, hand, recut type, saw blade thickness and part configuration should be verified, besides dimensions should be measured with caliper to ensure print specifications.Factors that could contribute to the reported event include segmentation error.The contribution of the device to the reported event could be corroborated as the device is out of specifications and the surgeon had to transition to standard instrumentation.Based on this investigation, the need for corrective action is not indicated as the failure mode rate is within the anticipated acceptable risk limit in the risk management plan.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, 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: 14316602
• Report Number: 1020279-2022-02224
• Device Sequence Number: 12068160
• Product Code: JWH
• UDI-Device Identifier: 00885556656563
• UDI-Public: 00885556656563
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K170282
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/14/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/29/2022
• Device Model Number: V0200108
• Device Catalogue Number: V0200109
• Device Lot Number: 00221408V1
• 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: 04/12/2022
• Supplement Date Received by Manufacturer: 06/14/2022; 10/12/2022
• Initial Report FDA Received Date: 05/07/2022
• Supplement Report FDA Received Date: 06/15/2022; 10/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2021
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown