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

Model Number	V0200112
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Defective Device (2588)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/24/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the visionaire femur block did not fit patient anatomy.Fault in device was noticed during surgery.The procedure was completed with a sn backup device.A surgical delay less or equal to 30 min was reported.The outcome of the patient is still unknown.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was not returned for evaluation.The pictures provided were reviewed and could not confirm the stated failure mode.The clinical/medical investigation concluded that, per complaint details, it was noted during the procedure that the visionaire femur block did not fit the patient anatomy.Reportedly, the procedure was completed with a s+n backup device with a 0-30 min surgical delay.Patient injury was not reported.The provided intra-op photos were reviewed and appear to show a gap between the block and bone; however, they do not provide insight into the root cause of the reported event.The requested clinical documentation was not provided.The engineering evaluation was performed and reported ¿no root cause could be found for the complaint.All parts of the design were within visionaire standards.No corrective action required.¿ based on the information provided, the clinical root cause of the reported event could not be concluded.The patient impact beyond the use of a back up device to complete the procedure and the reported 0-30 minute surgical delay could not be determined; however, no patient injury was reported.No further medical assessment could be rendered at this time.Should clinically relevant documentation/information and/or the product evaluation conclusion result in findings which are deemed clinically relevant, 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.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible probable cause could include but not limited to procedural variance or user error.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
• MDR Report Key: 10551740
• Report Number: 1020279-2020-04651
• Device Sequence Number: 3538256
• Product Code: JWH
• UDI-Device Identifier: 00885556658406
• UDI-Public: 00885556658406
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K170282
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2021

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: 01/26/2021
• Device Model Number: V0200112
• Device Catalogue Number: V0200112
• Device Lot Number: 00182596V1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/24/2020
• Supplement Date Received by Manufacturer: 08/17/2021
• Initial Report FDA Received Date: 09/17/2020
• Supplement Report FDA Received Date: 08/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1