MAUDE Adverse Event Report: SMITH & NEPHEW, INC. VISIONAIRE LT CUTTING BLOCK KIT - LGNP; PRSTHSS,KNEE,PTELLFMROTIBL,SMI-CNSTRND, CEMENTED, POLYMER/METAL/POLYMER

Catalog Number	V0100022
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/08/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tibia block would not fit.Mechanical instruments had to be used.No delay or injury reported.
Additional Manufacturer Narrative
The associated legion visionaire cutting block kit was returned and evaluated.The visual inspection of the returned device shows no obvious damage on the part.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 errors were made during the segmentation of the tibia.These errors would have affected block fit and could have caused the issues described in the complaint.Consequently, the alignment engineer along with the segmenter have taken steps to ensure that all surgeon preferences are met going forward.At this time we feel these actions will prevent recurrence of this failure.Our clinical evaluation noted that per the report the surgeon increased his incision proximally and cleared away soft tissue.As the tibial block did not fit the surgeon had to abort the visionaire block and use standardized/mechanical instrumentation to complete the procedure within a 5 10 minute surgical extension without patient injury.We will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.A review of relevant clinical/medical information in the reported issue, inclusive of technique and patient information, to include, but not limited to: ¿patient information ¿surgical procedure/post-operative care review ¿device labeling (including technique guides, ifus, etc.) it was communicated that the femoral block did not fit well but the surgeon increased his incision proximally and cleared away soft tissue.The tibial block, however, did not fit and the surgeon had to abort the visionaire block and use standardized/mechanical instrumentation to complete the procedure within a 5-10 minute surgical extension without patient injury.The engineering evaluation ¿determined that errors were made during the segmentation of the tibia¿ and would have ¿affected block fit and could have caused the issues described in the complaint¿.Corrective actions have been taken to mitigate future instances.In conclusion: based on the engineering evaluation the root cause of the block fit was incorrect segmentation.Due to the surgeon aborting the visionaire cutting plan and resorting to standardized/mechanical instrumentation the patient impact was minimized to the 5-10 minute surgical extension and an increased proximal incision without injury or further complications.No further medical assessment can be rendered at this time.Mi report approved by md justin templeton on 6/23/2019.Mimb review.Assess severity of complaint case to determine if additional actions or inputs are required for inclusion in the medical assessment.Determine if a medical assessment will be performed based on a review of the complaint details and further input from the medical director/designee.Reviewed during mimb.A medical investigation will be performed.Wait on product evaluation if the device is returning and/or the engineering evaluation.Proceed based on information provided and/or available for the investigation; if no relevant clinical information is provided, recommend closure.Approved by dr.Luca orlandini and/or j.Templeton, medical director.

• Brand Name: VISIONAIRE LT CUTTING BLOCK KIT - LGNP
• Common Device Name: PRSTHSS,KNEE,PTELLFMROTIBL,SMI-CNSTRND, CEMENTED, POLYMER/METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8292440
• Report Number: 1020279-2019-00355
• Device Sequence Number: 1098380
• Product Code: JWH
• UDI-Device Identifier: 03596010653130
• UDI-Public: 03596010653130
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 06/30/2019

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 Catalogue Number: V0100022
• Device Lot Number: 00127122V2
• Initial Date Received by Manufacturer: 01/09/2019
• Supplement Date Received by Manufacturer: 06/26/2019
• Initial Report FDA Received Date: 01/31/2019
• Supplement Report FDA Received Date: 06/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1