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

Model Number	V0200110
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	11/10/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during surgery, the visionaire adaptive guide distal femur journey ii block did not fit correctly.Procedure continued with a change in surgical technique and with a delay of less than 30 minutes.The patient was not harmed beyond the described event.
Event or Problem Description
It was reported that, during surgery, the visionaire adaptive guide distal femur journey ii block did not fit correctly.Procedure continued with a change in surgical technique and with a delay of less than 30 minutes.No additional bone cuts were performed and the patient was not harmed beyond the described event.
Additional Manufacturer Narrative
H3, h6|: the device was not returned for evaluation.The pictures provided were reviewed and could not confirm the stated failure mode, however an engineering evaluation was conducted and did confirm a potential root cause for the stated failure mode.The clinical/medical investigation concluded that, per complaint details, the visionaire adaptive guide distal femur journey ii block did not fit correctly; therefore, the surgeon completed the case with a change in surgical technique using standardized instrumentation within a 0-30 minute surgical extension.Reportedly, the patient was not harmed beyond the described event and there is ¿no anticipated patient impact¿.It was communicated that the blocks were ¿trashed¿ even though a request was made to keep them.The provided pre-op full leg x-ray does not provide insight into the reported event.Patient impact beyond the reported modified surgical procedure and < 30 minute surgical delay would not be anticipated as no patient injury was reported.No further medical assessment could be rendered at this time.Should clinically relevant documentation/information become available, the clinical/medical task may be re-evaluated.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.An engineering evaluation was conducted and determined that a portion of the anterior femur osteophyte was undersegmented.A historical review concluded that there are no prior actions related to this product and event.At this time, we 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 surgical technique used, user/procedural variance or segmentation error.The contribution of the device to the reported event could not be corroborated.This issue was evaluated through our internal quality process and determined that the failure mode rate is within the anticipated risk limit.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.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 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: 10937129
• Report Number: 1020279-2020-06922
• Device Sequence Number: 19898235
• Product Code: JWH
• UDI-Device Identifier: 00885556656570
• UDI-Public: 00885556656570
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/12/2022

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: 04/17/2021
• Device Model Number: V0200110
• Device Catalogue Number: V0200112
• Device Lot Number: 00187228V1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 11/10/2020
• Supplement Date Received by Manufacturer: 12/10/2020; 05/11/2022
• Initial Report FDA Received Date: 12/02/2020
• Supplement Report FDA Received Date: 12/16/2020; 05/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2020
• 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