MAUDE Adverse Event Report: SMITH & NEPHEW, INC. VISIONAIRE LT CUTTING BLOCK KIT - LGNP; PROSTHSIS,KNEE,PATELLFMRTIBIL,SMICONSTRAIND,CMNTD,POLYMR/METL/POLYMR

Catalog Number	V0100022
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/01/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a sizing and femoral rotation discrepancy was identified during a total knee using a visionaire cutting block.The visionaire plan was determined to be a 7 femur and 5 tibia.Once the distal femur was resected and sz 7 4 in 1 femoral block was visualized on bone it was apparent the sizing was off.At this point dr.Snyder observed the femoral rotation to be too external as well.To correct this we used standard instrumentation to size the femur to size 6, and also adjusted the rotation approx.3-4 degrees internal.The patient was not harmed or surgery delayed since all instrumentation and implants were available.Hospital threw blocks in trash, so nothing is available to return for review.
Additional Manufacturer Narrative
The associated visionaire cutting block kit was not returned for evaluation.Our investigation including an engineering evaluation by our visionaire team revealed that the femoral component was incorrectly rotated by 3 degrees.A possible hypoplastic medical condyle could have been a contributing factor.However, no root cause could be found for the sizing portion of the complaint.The femur was sized according to visionaire standards.Corrective actions have been implemented to help eliminate this issue from recurrence.The visionaire team has taken steps to ensure that all surgeon preferences are met going forward.No further actions are being taken at this time.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: PROSTHSIS,KNEE,PATELLFMRTIBIL,SMICONSTRAIND,CMNTD,POLYMR/METL/POLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7781014
• Report Number: 1020279-2018-01520
• Device Sequence Number: 1757856
• Product Code: JWH
• UDI-Device Identifier: 03596010653130
• UDI-Public: 03596010653130
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 11/13/2018

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 Catalogue Number: V0100022
• Device Lot Number: 00117944V1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/01/2018
• Supplement Date Received by Manufacturer: 08/01/2018
• Initial Report FDA Received Date: 08/14/2018
• Supplement Report FDA Received Date: 11/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1