MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG VIS CUT GUIDE JBCS KIT RT; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMI-CNSTRND,CEMENTED,POLY/METAL/POLY

Catalog Number V0100033

Device Problem Patient-Device Incompatibility (2682)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/17/2020

Event Type  Injury  

Event Description

It was reported that during a tka procedure, it was found that both femur and tibia blocks did not fit at all.Surgeon completed case with standard instruments.A delay no greater than 30 min was reported.

Manufacturer Narrative

H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.The contribution of the device to the reported event could not be corroborated.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.The instructions for use documents revealed that it instructs user to revert to standard instruments should device performance be unsatisfactory.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible causes could include but not limited to surgical technique used, user/procedural variance or segmentation error.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: VIS CUT GUIDE JBCS KIT RT
• Type of Device: PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMI-CNSTRND,CEMENTED,POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• Manufacturer Contact: sarah freestone ; 1450 brooks road; memphis, TN 38116 ; 0447940038
• MDR Report Key: 10258950
• MDR Text Key: 198371420
• Report Number: 9613369-2020-00138
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082358
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/03/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 09/08/2020
• Device Catalogue Number: V0100033
• Device Lot Number: 00167541
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/17/2020
• Initial Date FDA Received: 07/10/2020
• Supplement Dates Manufacturer Received: 02/02/2022
• Supplement Dates FDA Received: 02/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention