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

H10: after further assessment of the information gathered by the manufacturer, it was identified that this event should be re-evaluated for mdr reporting.The original information stated that, during a tka procedure, it was found that both femur and tibial cutting blocks included in vis cut guide jbcs kit rt did not fit at all.Surgeon completed case with standard instrumentation.A delay no greater than 30 min was reported.No patient harm was reported to occur as a consequence of this malfunction.However, after further clarification and information received, it was determined that the present complaint does not meet the criteria to be reportable nor to be a complaint, because the two devices involved: the femoral and the tibial cutting blocks, are included in the vis cut guide jbcs kit rt.Therefore, the report already submitted (report number: 9613369-2020-00138) covers the malfunction of both devices.

• 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
• MDR Report Key: 10259245
• MDR Text Key: 198381255
• Report Number: 9613369-2020-00139
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• PMA/PMN Number: K082358
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/01/2021

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 Catalogue Number: V0100033
• Initial Date Manufacturer Received: 06/17/2020
• Initial Date FDA Received: 07/10/2020
• Supplement Dates Manufacturer Received: 06/17/2020
• Supplement Dates FDA Received: 10/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention