MAUDE Adverse Event Report: SMITH & NEPHEW, INC. VISIONAIRE JII FEMORAL CUTTING BLOCK; PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT

Model Number	V0100080
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	Injury (2348)
Date of Event	09/26/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during surgery, the surgeon changed the cutting block from visionaire to standard one for cutting further.However, the two pins didn't fit into the pinholes on the standard one.It seemed that the length between the two pinholes on visionaire cutting block were not the same with the standard one.No harm to the patient.3 minutes delay.The device will be returned for evaluation.Additionally, case was sent with gii mis style pinholes when japan should only receive journey i style pinholes for all journey ii cases.
Additional Manufacturer Narrative
It was reported that during surgery, the surgeon changed the cutting block from visionaire to standard one for cutting further.However, the two pins didn¿t fit into the pinholes on the standard one.It seemed that the length between the two pinholes on visionaire cutting block were not the same with the standard one.The affected complaint device, used in treatment, was returned and evaluated.Visual inspection of the returned device showed dark stains on the part but no obvious damage.A review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Our investigation including an engineering review by our visionaire team noted that after evaluation, it was found that the engineer did not select the correct expression for a journey i femur block.A relationship, if any, between the device and the reported incident is corroborated.The possible potential root cause of this failure is determined as human error.The responsible alignment engineer is no longer in this position, therefore the 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 additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: VISIONAIRE JII FEMORAL CUTTING BLOCK
• Common Device Name: PROSTH, HIP, SEMI-CONST, MET/CERAM/POLY, CEMENT OR NON-POROUS, UNCEMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9241912
• Report Number: 1020279-2019-03741
• Device Sequence Number: 114433
• Product Code: JWH
• UDI-Device Identifier: 00885556492703
• UDI-Public: 00885556492703
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 07/06/2020

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: 02/24/2020
• Device Model Number: V0100080
• Device Catalogue Number: ORV0100080
• Device Lot Number: 00153028V1
• Initial Date Received by Manufacturer: 09/27/2019
• Supplement Date Received by Manufacturer: 07/01/2020
• Initial Report FDA Received Date: 10/25/2019
• Supplement Report FDA Received Date: 07/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1