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

Model Number V0100109

Device Problem Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/22/2019

Event Type  malfunction  

Event Description

It was reported that due to patient needs, the original visionaire plan was changed to legion.Visionaire team was aware of this change.During surgery, after the first cut was made with the visionaire instrument (which is the same for a journey or a legion according to the sales rep), the pinholes the instrument leaves did not align correctly with the next instrument that needed to be used.At this point, the labels were checked.The blocks were for a legion but were labeling as a journey ii.A change to standard instrumentation was made and a legion system was implanted.Reported delay 15 minutes.

Manufacturer Narrative

The device used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical analysis confirmed that reportedly, the ¿blocks were for a legion¿ but labeled as journey ii¿; therefore, the surgeon changed to standard instrumentation to implant the legion system within a 15 minute surgical extension.Per the pre-op plan ¿notes¿: ¿3 degrees external from whiteside¿s line.Implant switched to journey ii per request¿.It was further communicated that there was no injury to the patient and the blocks were disposed of and will not be returning.The patient impact beyond the reported minor 15 minute surgical extension is not anticipated as the preferred lgn system was reportedly implanted with standard instrumentation.Should clinical documentation become available in the future, the clinical/medical task may be re-evaluated.No further medical assessment is warranted at this time.A review of the manufacturing records did not reveal any manufacturing or material abnormalities 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.After evaluation by the visionaire tem, it was determined that the alignment engineer made the requested changes to the blocks, but did not update the implant selection in crm, the export label, or the surgical preference sheet pdf.Additionally, the exporter overlooked this error.No root cause could be found for the pinholes not matching the 4-in-1 cutting block.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 warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: VIS ADPT GUIDE KIT JII
• Type of Device: PROSTHESIS, KNEE, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9720401
• MDR Text Key: 182336787
• Report Number: 1020279-2020-00613
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00885556656396
• UDI-Public: 00885556656396
• Combination Product (y/n): N
• PMA/PMN Number: K170282
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/23/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 03/16/2020
• Device Model Number: V0100109
• Device Catalogue Number: V0100112
• Device Lot Number: 00156427V1
• Initial Date Manufacturer Received: 10/22/2019
• Initial Date FDA Received: 02/18/2020
• Supplement Dates Manufacturer Received: 07/22/2020
• Supplement Dates FDA Received: 07/23/2020
• Patient Sequence Number: 1