MAUDE Adverse Event Report: SMITH & NEPHEW, INC. VIS ADPT GUIDE GII KIT; PROSTHESIS, KNEE, PATELFEMOTIBL, SEMI-CONSTR, CEMENT, POLY/METAL/POLY

Model Number	V0100106
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Tissue Injury (4559); Insufficient Information (4580)
Date of Event	09/19/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during a tka surgery, using a visionaire adaptive guide kit genesis ii, the femoral block was directed and did not force over the distal lateral condyle.The distal femur was cut, the resections were measured and had to cut an extra 4mm.It is unknown if there was any delay as a consequence of this problem.Current health status of paient is unknown.
Additional Manufacturer Narrative
Internal reference: (b)(4).
Additional Manufacturer Narrative
H3, h6.The device was not returned for evaluation; therefore, a device analysis could not be performed.However, a review made by the quality engineering team revealed that the alignment engineer set the distal femur resection 2mm conservative to the requested 11.5 mm resection.This engineer could not be retrained or informed of this complaint due to them no longer working with the visionaire team.The clinical/medical investigation concluded that, per the complaint details, the distal femoral cut had to increase by 4mm after measuring resections.Reportedly, ¿fit femoral block as directed and did not force over distal lateral condyle¿.As of the date of this medical investigation, the requested clinical documentation has not been provided; therefore, there were no clinical factors found which would have contributed to the reported event.The patient impact beyond the reported additional 4mm distal femur resection cannot be determined and the current patient status remains unknown.No further medical assessment is warranted 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.As visionaire devices are custom made devices, a review of the complaint history for this part is not applicable.A review of the instructions for use documents for visionaire¿ patient matched instrumentation with fastpak instruments revealed that if the patient matched cutting block does not perform as intended, use the standard smith & nephew instrumentation to complete the surgery.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, final inspection includes the verification of part configuration per print.Also the device should be measured with a caliper to ensure the correct size.At this time, we do have reason to suspect that the product failed to meet specifications at the time of manufacture.The root cause of this event was determined to be the set of the distal femur resection 2mm conservative with respect to the requested 11.5mm resection.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.H11: corrected information in h6 (health effect - clinical code and health effect - impact code).

• Brand Name: VIS ADPT GUIDE GII KIT
• Common Device Name: PROSTHESIS, KNEE, PATELFEMOTIBL, SEMI-CONSTR, CEMENT, POLY/METAL/POLY
• 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: 15577956
• Report Number: 1020279-2022-04391
• Device Sequence Number: 17833431
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2023

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 Model Number: V0100106
• Device Catalogue Number: V0100106
• Device Lot Number: 00237883V1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2022
• Supplement Date Received by Manufacturer: 06/02/2023
• Initial Report FDA Received Date: 10/11/2022
• Supplement Report FDA Received Date: 06/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male