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

Catalog Number	V0100022
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Codes	Tissue Damage (2104); No Consequences Or Impact To Patient (2199); Injury (2348)
Date of Event	03/19/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during surgery the visionaire tibial cutting block did not make correct cuts.The procedure was completed using a backup device with a delay of less than 30 minutes.
Event or Problem Description
It was reported that during surgery the visionaire tibial cutting block did not make correct cuts.Surgeon had to use s&n manual instrumentation as the backup to complete the surgery, diverting from the original technique, and made extra proximal tibial resection to balance the knee.The final outcome of the patient so far so good.Surgeon was very unhappy with the blocks, the procedure was delayed for less than 30 minutes.
Additional Manufacturer Narrative
The associated visionaire guide kit was returned and evaluated.A visual inspection of the returned device noted no obvious damage.Our investigation including an engineering analysis by our visionaire team noted that all alignment parameters were evaluated.An error found during geomagic evaluation was determined to be minimal, having no effect on block fit or resection depth referencing.No root cause could be determined for incorrect resections.A clinical evaluation noted that no root cause could be determined for the reported incorrect resections as the minor geomagic error noted during the investigation does not make contact with the cutting guides and had ¿no effect on block fit or resection depth referencing¿.No further patient impact is anticipated as it was communicated no impact/injury resulted from the standardized procedure and/or the minor surgical delay.A relationship, if any, between the device and the reported incident or adverse event could not be corroborated.The review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.No further investigation is warranted for this complaint; however, smith and nephew will continue to monitor for future complaints and investigate as necessary.Should additional information be received, this complaint will be reopened and reevaluated.

• Brand Name: VISIONAIRE LT CUTTING BLOCK 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: 8495400
• Report Number: 1020279-2019-01469
• Device Sequence Number: 13861472
• Product Code: JWH
• UDI-Device Identifier: 03596010653130
• UDI-Public: 03596010653130
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/01/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/24/2019
• Device Catalogue Number: V0100022
• Device Lot Number: 00135799V1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2019
• Initial Date Received by Manufacturer: 03/19/2019
• Supplement Date Received by Manufacturer: 04/22/2019; 04/22/2019
• Initial Report FDA Received Date: 04/09/2019
• Supplement Report FDA Received Date: 04/23/2019; 10/01/2019
• 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: Other