MAUDE Adverse Event Report: SMITH & NEPHEW, INC. NON STRL VISIONAIRE RT CUT BLK KIT LGNP; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	V0200023
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/27/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during surgery, using a visionaire block which fitted perfectly on the femur, a cut that was 2 mm more than the planned was made.It is unknown how was the procedure concluded.
Additional Manufacturer Narrative
The associated visionaire cutting block kit was not returned for evaluation.Therefore a product analysis could not be performed.The review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.Our investigation including an engineering analysis by our visionaire team noted that all alignment parameters were evaluated and found them to be within visionaire standards.No root cause could be determined.A clinical evaluation noted that without clinically relevant documentation and based solely on the engineering evaluation, additional posterior debris during measurements and/or placement of the 4-in-1 in slight rotation could have been possible contributing factors to the reported event, as manufacturing was within standards.Patient impact beyond the reported additional 2mm cut could not be definitively determined, as the patient¿s post-operative outcome/status was not provided.A relationship, if any, between the device and the reported incident or adverse event could not be corroborated.No further investigation is warranted for this complaint; however, smith and nephew will continue to monitor for future complaints and investigate as necessary.

• Brand Name: NON STRL VISIONAIRE RT CUT BLK KIT LGNP
• 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: 8713154
• Report Number: 1020279-2019-02340
• Device Sequence Number: 16609349
• Product Code: JWH
• UDI-Device Identifier: 00885556583074
• UDI-Public: 00885556583074
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2019

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: 10/30/2019
• Device Catalogue Number: V0200023
• Device Lot Number: 00144411V1
• Initial Date Received by Manufacturer: 05/28/2019
• Supplement Date Received by Manufacturer: 05/28/2019
• Initial Report FDA Received Date: 06/19/2019
• Supplement Report FDA Received Date: 10/02/2019
• 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