MAUDE Adverse Event Report: SMITH & NEPHEW, INC. NON STRL VISIONAIRE RT CUT BLK KIT GII; PRSTHSS,KNEE,PATELLOFEMOROTIBIAL,SEMI-CONSTRAINED,CEMENTED,POLYMER/METAL/POLYMER

Catalog Number	V0200013
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/22/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during procedure block did not fit properly on the medial condyle of the femur and when pinned caused the rotation to be thrown off.Standard instrumentation available and used.No injuries or delays reported.
Additional Manufacturer Narrative
T was reported that during procedure block did not fit properly on the medial condyle of the femur and when pinned caused the rotation to be thrown off.Standard instrumentation available and used.The associated genesis ii visionaire cutting block kit was not returned for evaluation.Therefore, a product analysis could not be conducted.A review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.No prior complaints for this part as this is a patient specific device.Our investigation including an engineering evaluation by our visionaire team found that all in the planning and design process were within visionaire standards.No root cause could be determined.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A relationship, if any, between the device and the reported incident or adverse event could not be corroborated.Without the return of the actual product involved, our investigation of this report is inconclusive.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however smith and nephew will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.

• Brand Name: NON STRL VISIONAIRE RT CUT BLK KIT GII
• Common Device Name: PRSTHSS,KNEE,PATELLOFEMOROTIBIAL,SEMI-CONSTRAINED,CEMENTED,POLYMER/METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9359291
• Report Number: 1020279-2019-04130
• Device Sequence Number: 2237175
• Product Code: JWH
• UDI-Device Identifier: 00885556583036
• UDI-Public: 00885556583036
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/26/2019

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: V0200013
• Initial Date Received by Manufacturer: 10/22/2019
• Supplement Date Received by Manufacturer: 10/22/2019
• Initial Report FDA Received Date: 11/21/2019
• Supplement Report FDA Received Date: 12/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1