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

Model Number	V0100106
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference case: (b)(4).
Event or Problem Description
It was reported that, during a tka surgery, the surgeon was dissatisfied with the fit of the vis adpt guide gii kit because was not sitting flush on the lateral side, however, it was completely flush with the medial side.Surgery was resumed, with a less than or equal to 30 minutes delay.It is unknown how the procedure was finished.Patient was not injured as consequence of this problem.
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation but the reported event could be confirmed since the image provided showed that the device is not fully seated and the engineering evaluation found errors in the segmentation of the tibia and the smoothing process.The clinical/medical investigation concluded that, no relevant clinical information has been provided; therefore, a thorough medical investigation could not be rendered.Based solely on the engineering evaluation, ¿a potential root cause for the stated failure mode was confirmed.The evaluation found that there were errors in the segmentation of the tibia which would have affected block fit.It was also determined that an error occurred in the smoothing process of the medial anterior block fit area of the tibia.This too would have affected the block fit¿.Subsequently, per the customer feedback form, ¿the surgeon was dissatisfied with the fit of the vis adpt guide gii kit because was not sitting flush on the lateral side, however, it was completely flush with the medial side¿.Reportedly, this was depicted in the undated, unlabeled photo attached in this case.It was reported, the surgeon was able to resume the procedure with a less than or equal to 30 minutes delay.The visionaire¿ surgical technique does recommend use of back-up instrumentation should the adaptive guide be determined unsuitable for its intended use.Consequently, it is unknown how the procedure was completed.Since it was reported there was no harm alleged to this patient, no further clinical/medical assessment is warranted at this time.Should any additional relevant medical information be provided, this cause would be re-assessed.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.According to the drawing print, dimensions are case-specific.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.An assessment made by a quality engineer was performed and did confirm a potential root cause for the stated failure mode.At this time, we do have reason to suspect that the product failed to meet product specifications at the time of manufacture.Possible causes could include but not limited to errors during manufacturing process such as segmentation error and geomagic smoothing.The contribution of the device to the reported event could be corroborated as the device didn't align correctly and a delay during surgery.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 GII 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: 12787610
• Report Number: 1020279-2021-07981
• Device Sequence Number: 17677901
• Product Code: JWH
• UDI-Device Identifier: 00885556656365
• UDI-Public: 00885556656365
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/26/2022
• Device Model Number: V0100106
• Device Catalogue Number: V0100106
• Device Lot Number: 00214828V1
• 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: 10/19/2021
• Supplement Date Received by Manufacturer: 08/05/2022
• Initial Report FDA Received Date: 11/10/2021
• Supplement Report FDA Received Date: 08/11/2022
• Date Device Manufactured: 09/27/2021
• 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
• Patient Sex: Unknown