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	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/20/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the femoral guide broke during distal femoral resection.Backup metal cutting block was available.No additional time was added to procedure and patient care/safety was not affected.The broken part is available for return.
Additional Manufacturer Narrative
The associated journey ii visionaire cutting block kit was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The block is broken in pieces which are returned.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 discovered that the break was due to insufficient sintering of the material layers during the manufacturing process.Corrective actions are currently being considered.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.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: 8245835
• Report Number: 1020279-2019-00165
• Device Sequence Number: 2141824
• Product Code: JWH
• UDI-Device Identifier: 00885556492680
• UDI-Public: 00885556492680
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 05/14/2019

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: V0100082
• Device Lot Number: 00131007V1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2019
• Initial Date Received by Manufacturer: 12/21/2018
• Supplement Date Received by Manufacturer: 12/21/2018
• Initial Report FDA Received Date: 01/14/2019
• Supplement Report FDA Received Date: 05/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1