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

Model Number V0100106

Device Problem Device Handling Problem (3265)

Patient Problem No Information (3190)

Event Date 01/29/2020

Event Type  malfunction  

Event 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
• Type of Device: PROSTHESIS, KNEE, SMI-CONSTRAINED, CMNTD,PLYMER/MTL/PLYER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: sarah freestone ; 1450 brooks road
• MDR Report Key: 9859879
• MDR Text Key: 184280806
• Report Number: 1020279-2020-00949
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00885556656365
• UDI-Public: 00885556656365
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170282
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: No Information
• Device Model Number: V0100106
• Device Catalogue Number: V0100106
• Device Lot Number: 00165944
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/25/2020
• Initial Date FDA Received: 03/20/2020
• Supplement Dates Manufacturer Received: 12/09/2020
• Supplement Dates FDA Received: 12/14/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1