MAUDE Adverse Event Report: SMITH & NEPHEW, INC. VIS ADPT GUIDE KIT JII; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Model Number	V0100112
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during a total knee arthroplasty surgery, a visionaire adaptive guide jii femur block did not fit the anatomical site.Femur was upsized 2 sizes to size 8 and rotation was off.Surgery was performed with a change in the surgical technique, after a non-significant delay.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 provided intraop photos appear to show space between the device and bone.The clinical/medical investigation concluded that, per complaint details, the femoral visionaire guide ¿did not fit the anatomical site¿rotation was off¿ and ¿was upsized 2 sizes to size 8¿.Reportedly, the surgery was performed with a change in the surgical technique, after a non-significant delay (0-30 minutes), and the patient was not injured as consequence of this problem.Although the provided intraop photos appear to show space between the device and bone which supports the complaint, the photos do not provide insight into the root cause of the reported event.Responses to the clinical documentation requests had not been provided as of the date of this medical assessment.The visionaire¿ surgical technique does recommend use of back-up instrumentation should the adaptive guide be determined unsuitable for its intended use.Based on the information provided, the clinical root cause could not be definitively concluded.Further patient impact would not be anticipated as the surgeon reportedly completed the procedure within a 0-30 minute surgical extension with a change of surgical technique and no patient injury was alleged.Based on this information, no further medical assessment is warranted at this time.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.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 segmentation engineer under segmented the anterior femur.Both the alignment and segmentation engineers were made aware of the issue and the subject matter expert reviewed procedure visionaire tka segmentation standards with them for clarity.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 segmentation error.The contribution of the device to the reported event could be corroborated since the block di not fit the anatomical site and the surgery was performed with a change in the surgical technique.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 KIT JII
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, 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: 12054199
• Report Number: 1020279-2021-05417
• Device Sequence Number: 11824759
• Product Code: JWH
• UDI-Device Identifier: 00885556656419
• UDI-Public: 00885556656419
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K170282
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2022

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 Model Number: V0100112
• Device Catalogue Number: V0100112
• Device Lot Number: 00203278
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2021
• Supplement Date Received by Manufacturer: 07/28/2022
• Initial Report FDA Received Date: 06/23/2021
• Supplement Report FDA Received Date: 08/02/2022
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Other
• Patient Sex: Unknown