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

Model Number	V0200012
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during a tka surgery, it was noticed that the ns vis cut guide gii kit lt design had a lateral cutting slot that made difficult to place the tibial cutting guide into the incision, which led to cut the distal twice and resect more proximal medial tibia twice.Surgery was resumed, with the same device and it is unknown if this problem provoked any delay.Patient was not harmed as consequence of this problem.
Additional Manufacturer Narrative
H3, h6: the associated device was returned and evaluated.A visual inspection of the returned device confirmed the device is broken.The device has scratches and burrs, rendering the device inoperative.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do have reason to suspect that the product failed to meet any product specifications at the time of manufacture.An engineering evaluation was performed and did confirm a potential root cause for the stated failure mode.The evaluation found that an error occurred during the tibia cutting guide creation.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.The alignment engineering team was made aware of the issue and the visionaire tka alignment standards were reviewed for clarity.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.As the device broke did not fit properly, the contribution of the device to the reported event could be corroborated.Based on this investigation, the need for corrective action is not indicated.This issue was evaluated through our internal quality process and determined to be within the anticipated acceptable risk limit so no additional actions will be taken at this time.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor future complaints and investigate as necessary.We consider this investigation closed.
Additional Manufacturer Narrative
The sample is under evaluation by manufacturing site.
Event or Problem Description
It was reported that, during a tka surgery, it was noticed that the ns vis adpt guide jii kit design had a lateral cutting slot that made difficult to place the tibial cutting guide into the incision, which led to two (2) cuts of the distal to 4mm, two (2) cuts of the proximal medial tibia to 4mm.Surgery was resumed, with the same device after a non-significant delay.Patient was not harmed as consequence of this problem.

• 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: 12338587
• Report Number: 1020279-2021-06459
• Device Sequence Number: 11868459
• Product Code: JWH
• UDI-Device Identifier: 00885556658406
• UDI-Public: 00885556658406
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K170282
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/26/2022

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: 01/18/2022
• Device Model Number: V0200012
• Device Catalogue Number: V0200112
• Device Lot Number: 00210030V1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2021
• Supplement Date Received by Manufacturer: 07/14/2022; 07/14/2022; 09/22/2022
• Initial Report FDA Received Date: 08/18/2021
• Supplement Report FDA Received Date: 07/14/2022; 08/29/2022; 09/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2021
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male