MAUDE Adverse Event Report: SMITH & NEPHEW, INC. VISIONAIRE LT CUTTING BLOCK KIT - LGNP; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number V0100022

Device Problem Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/13/2018

Event Type  Injury  

Event Description

Bad cutting slot.Slot seemed to be half filled in, kicked the saw blade when trying to cut.Had to recut with metal block because cut was uneven, ended up using stemmed tibia component.

Manufacturer Narrative

The associated visionaire cutting block kit was returned and evaluated.Our investigation including an engineering evaluation by our visionaire team noted that the block was damaged during surgery.The distal face of the cutting slot shows signs of damage caused by a reciprocating saw blade.This was the result of the teeth of the saw blade coming into contact with the distal surface of the slot while the blade was not parallel with the direction of the slot.To avoid this sort of damage to the block, the saw should be switched on only when the cutting tip of the saw blade exits the cutting slot and is in contact with the bone.A clinical evaluation indicated that the accidental intraoperative saw blade contact resulted in an incorrect tibial cut and an obstructed cutting block slot which required conversion to a revision left tibial component adding a minor surgical extension of 0-30 minutes.The patient impact was reportedly a minor surgical delay, an increased cost associated with the tibial mis-cut, and subsequent conversion to a revision component.Based on the information provided, a normal post-operative convalescence period is expected.No further medical assessment is warranted at this time.A review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.Should additional information be received, the complaint will be reopened.

• Brand Name: VISIONAIRE LT CUTTING BLOCK KIT - LGNP
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7716747
• MDR Text Key: 114930169
• Report Number: 1020279-2018-01397
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 03596010653130
• UDI-Public: 03596010653130
• Combination Product (y/n): N
• PMA/PMN Number: K082358
• 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: 11/02/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: V0100022
• Device Lot Number: 00116083
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/16/2018
• Initial Date FDA Received: 07/24/2018
• Supplement Dates Manufacturer Received: 07/16/2018
• Supplement Dates FDA Received: 11/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention