MAUDE Adverse Event Report: SMITH AND NEPHEW, INC. VISIONAIRE RT CUTTING BLOCK KIT - LGNP; PRSTHSIS,KNEE,PATELLOFMROTIBIAL,SMI-CNSTRND,CMNTD,POLYMR/METAL/POLYMER

Catalog Number	V0100023
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	09/14/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient had a tibia fracture.
Additional Manufacturer Narrative
The associated visionaire cutting block kit was not returned for evaluation.Our investigation from our visionaire team noted that after evaluation, no root cause could be found for the complaint.All steps in the planning and design were within visionaire standards.A review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.A clinical analysis noted that the reported fracture cannot be confirmed based solely on the provided images.In addition, without the requested explant, the visionaries¿ cutting plan, or the pre-revision x-rays, a thorough medical investigation cannot be conducted.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: VISIONAIRE RT CUTTING BLOCK KIT - LGNP
• Common Device Name: PRSTHSIS,KNEE,PATELLOFMROTIBIAL,SMI-CNSTRND,CMNTD,POLYMR/METAL/POLYMER
• Manufacturer (Section D): SMITH AND NEPHEW, INC.; 1450 brooks road; memphis, tennessee; memphis 38116
• MDR Report Key: 7945158
• Report Number: 1020279-2018-02115
• Device Sequence Number: 19210957
• Product Code: JWH
• UDI-Device Identifier: 03596010653147
• UDI-Public: 03596010653147
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K082358
• 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): 12/04/2018

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 Catalogue Number: V0100023
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/14/2018
• Supplement Date Received by Manufacturer: 09/14/2018
• Initial Report FDA Received Date: 10/08/2018
• Supplement Report FDA Received Date: 12/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other