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	Defective Component (2292)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/20/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the dr secured the femoral cutting guide, as usual, inserted the oscillating saw and proceeded with the distal cut of the femur.As he was cutting through, he noticed plastic shavings in the cut.He said that he had felt that there was an obstruction in the guide as if the slot wasn't completely open.No injury was reported.Procedure completed with the same device.
Additional Manufacturer Narrative
The affected visionaire cutting block kit was returned and evaluated.A visual inspection of the block confirmed the stated failure.The material debris are observed around the cutting slots of the device.Our investigation including an engineering analysis by our visionaire team revealed that after evaluation, it was determined that the debris in the cutting slot of the femur block was caused intraoperatively by the teeth of the oscillating saw blade coming into contact with the inner surface of the cutting slot while the saw was turned on.To avoid this phenomenon, the saw should not be turned on until the saw blade is fully inserted into the slot and the teeth of the blade are contacting the bone.A 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 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: 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: 8497502
• Report Number: 1020279-2019-01483
• Device Sequence Number: 1062181
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2019

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 Expiration Date: 08/13/2019
• Device Catalogue Number: V0200023
• Device Lot Number: 00135787V1
• Initial Date Received by Manufacturer: 03/20/2019
• Supplement Date Received by Manufacturer: 03/20/2019
• Initial Report FDA Received Date: 04/09/2019
• Supplement Report FDA Received Date: 07/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1