MAUDE Adverse Event Report: SMITH & NEPHEW, INC. VIS ADPT GUIDE KIT JII; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	V0100112
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during tka surgery the doctor pinned the visionaire femoral guide into place and made his distal femoral cut.When he put the size 4 planned size cutting guide into the pre drilled holes it seemed to have put them into extreme external rotation and would have taken off and estimated 15+ mm of bone off the posterior medial side.He then decided to change to conventional instrumentation and sized the femoral to a size 5 and the rotation was put correctly to 3 degrees of external rotation.They then used the visionaire tibial cutting guide and seemed to line up correctly and made the resection.When they checked the pre drilled tibial rotation, it again was extremely externally rotated.We then corrected that inter-op and sized it up one size from a 2 to a 3.Patient was not harmed as consequence of this problem.It is unknown if there was a surgical delay.
Additional Manufacturer Narrative
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 tka surgery, the doctor pinned the visionaire femoral guide into place and made his distal femoral cut.When he put the size 4 planned size cutting guide into the pre-drilled holes it seemed to have put them into extreme external rotation and would have taken off and estimated 15+ mm of bone off the posterior medial side.He then decided to change to conventional instrumentation and sized the femoral to a size 5 and the rotation was put correctly to 3 degrees of external rotation.They then used the visionaire tibial cutting guide and seemed to line up correctly and made the resection.When they checked the pre-drilled tibial rotation, it again was extremely externally rotated.We then corrected that inter-op and sized it up one size from a 2 to a 3.The procedure was completed with a delay of less than 30 minutes.Patient was not harmed as 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: 1020279-2021-05537) covers the malfunction of both devices.

• Brand Name: VIS ADPT GUIDE KIT JII
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12086387
• Report Number: 1020279-2021-05535
• Device Sequence Number: 11594248
• Product Code: JWH
• UDI-Device Identifier: 00885556656419
• UDI-Public: 00885556656419
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K170282
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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?: Yes
• Operator of Device: Health Professional
• Device Model Number: V0100112
• Device Catalogue Number: V0100112
• Device Lot Number: 00202490V2
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/14/2021
• Supplement Date Received by Manufacturer: 06/14/2021
• Initial Report FDA Received Date: 06/29/2021
• Supplement Report FDA Received Date: 10/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention