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

Catalog Number	V0100022
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/20/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, the distal holes for spikes on dcf 4in1 cutting block prepared through visionaire mold.When attempting to place dcf 4in1 cutting block on prepared surface the spikes did not line up with the prepared holes.Was off by approximately 1-2mm.When comparing the mold to the spikes on the blocks on the distal surface of the mold they were aligned, however it was not aligned on the proximal surface of the mold.This was compared in multiple sizes to rule out block spike bending.Surgeon had to reverted to a manual tkr, simply completed procedure without the use of visionaire block.There was a delay shorter than 30 minutes.Final outcome of the patient was fine.
Additional Manufacturer Narrative
The associated visionaire cutting block kit was returned for evaluation.A visual inspection of the returned part indicated no obvious signs of damage.A review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.Our investigation including an engineering evaluation by our visionaire team noted that after evaluation, it was determined that the femur block was designed and manufactured with the correct pinhole spacing.A dimensional evaluation noted the calculated distance is within print specification.No root cause for complaint description could be determined by dimensional evaluation.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
• Common Device Name: PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAINED,CEMENTED,POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8161918
• Report Number: 1020279-2018-02785
• Device Sequence Number: 2370568
• Product Code: JWH
• UDI-Device Identifier: 03596010653130
• UDI-Public: 03596010653130
• Combination Product (Y/N): N
• PMA/510(K) Number: K082358
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2019

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: Health Professional
• Device Expiration Date: 03/31/2019
• Device Catalogue Number: V0100022
• Device Lot Number: 00124911V1
• Initial Date Received by Manufacturer: 11/20/2018
• Supplement Date Received by Manufacturer: 11/20/2018
• Initial Report FDA Received Date: 12/13/2018
• Supplement Report FDA Received Date: 02/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1