MAUDE Adverse Event Report: SMITH & NEPHEW, INC. VIS ADPT GUIDE GII KIT; PRSTHSIS, KEE, PTLLOFEMROTIBIL, SMI-CONSTRIND, CMNTD, PLY/MTL/POLYMR

Model Number	V0100106
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/03/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that before the procedure, it was discovered that the labeling on the ag visionaire cutting block packaging was incorrect.Surgeon decided to use the device anyway.Surgical delay information was not provided initially.
Additional Manufacturer Narrative
It was reported that before the procedure, it was discovered that the labeling on the ag visionaire cutting block packaging was incorrect.Surgeon decided to use the device anyway.The affected complaint device, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.Our investigation including an engineering review by our visionaire team noted that after evaluation it was found that all aspects of the alignment were within the visionaire standards.Our investigation including a review of the manufacturing records for the listed batch revealed there was a failure to update the labeling when a change requested by the surgeon occurred.There was a change to the femoral device sizing from an 8 to a 9.There was a failure to update shop order paperwork and labeling.At this time, we have a reason to suspect that the product failed to meet any product specifications at the time of manufacture.A relationship, if any, between the label and the reported incident is be corroborated.Based on this investigation, the corrective action has been implemented.The visionaire team including the schedulers and the shop floor personel have taken steps to ensure that all surgeon preferences are met going forward.At this time we feel these actions will prevent recurrence of this failure.The failure was determined to be a human error.No further investigation is warranted for this complaint; however smith and nephew will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: VIS ADPT GUIDE GII KIT
• Common Device Name: PRSTHSIS, KEE, PTLLOFEMROTIBIL, SMI-CONSTRIND, CMNTD, PLY/MTL/POLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9831064
• Report Number: 1020279-2020-00869
• Device Sequence Number: 16328690
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2020

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 Expiration Date: 07/25/2020
• Device Model Number: V0100106
• Device Catalogue Number: V0100106
• Device Lot Number: 00164108V1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/03/2020
• Supplement Date Received by Manufacturer: 11/11/2020
• Initial Report FDA Received Date: 03/13/2020
• Supplement Report FDA Received Date: 11/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1