MAUDE Adverse Event Report: SMITH & NEPHEW, INC. VIS ADPT GUIDE GII KIT; PROSTHESIS, KNEE, SMI-CONSTRAINED, CMNTD,PLYMER/MTL/PLYER

Model Number	V0100106
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/29/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the saw blade did not fit through distal femur cutting slot.Double downsized femur from size 7 to size 5.Not nearly enough external rotation of component incorporated into tibia cutting guide.It is unknown how was the procedure completed.

• Brand Name: VIS ADPT GUIDE GII KIT
• Common Device Name: PROSTHESIS, KNEE, SMI-CONSTRAINED, CMNTD,PLYMER/MTL/PLYER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9859879
• Report Number: 1020279-2020-00949
• Device Sequence Number: 11596135
• Product Code: JWH
• UDI-Device Identifier: 00885556656365
• UDI-Public: 00885556656365
• Combination Product (Y/N): N
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2020

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
• Operator of Device: No Information
• Device Model Number: V0100106
• Device Catalogue Number: V0100106
• Device Lot Number: 00165944
• Initial Date Received by Manufacturer: 02/25/2020
• Supplement Date Received by Manufacturer: 12/09/2020
• Initial Report FDA Received Date: 03/20/2020
• Supplement Report FDA Received Date: 12/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1