MAUDE Adverse Event Report: SMITH & NEPHEW, INC. VISIONAIRE JII CUTTING BLOCK KIT- LEFT; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	V0100082
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	Injury (2348)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that visionaire cutting block on femoral side did not fit appropriately ( the anterior portion of block curved up and did not match anatomy of bone) as such surgeon and clinical nurse held and pinned the block manually where they felt was appropriate.The anterior cortex was notched, that area was grafted by patient¿s host bone when components were implanted.Minor delay reported.
Additional Manufacturer Narrative
The associated visionaire cutting block kit was returned and evaluated.A visual inspection of the returned device shows no obvious damage on the device.Our investigation including an engineering analysis by our visionaire team indicated that after evaluation, it was determined that a portion of the anterior osteophyte on the femur was under-segmented.Additionally, there was a smoothing error caused by over-sanding in the same area of the anterior femur.These errors together could have caused the femur block to fit in a way that would result in an anterior slope of the distal cut of the femur.This could have caused the notching described in the complaint.After the execution of this case, it was discovered that there was higher occurrence of over-sanding during the smoothing process due to the use of a new segmentation software, since then, all employees involved in smoothing have been retrained to avoid the problem in the future.At this time we feel these actions will prevent recurrence of this failure.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.A clinical evaluation noted that patient impact beyond the reported femoral notching, minor surgical extension, periprosthetic fracture, probable pain and hospitalization course for revision and infection cannot be determined.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 JII CUTTING BLOCK KIT- LEFT
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8610487
• Report Number: 1020279-2019-01935
• Device Sequence Number: 16705906
• Product Code: JWH
• UDI-Device Identifier: 00885556492680
• UDI-Public: 00885556492680
• 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: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2019

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 Expiration Date: 06/17/2019
• Device Catalogue Number: V0100082
• Device Lot Number: 00132200V1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2019
• Initial Date Received by Manufacturer: 04/23/2019
• Supplement Date Received by Manufacturer: 04/23/2019
• Initial Report FDA Received Date: 05/14/2019
• Supplement Report FDA Received Date: 07/10/2019
• 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: Hospitalization; Required Intervention