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

Model Number	V0100109
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Mechanics Altered (2984)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that the vis adpt guide lgnp kit was off, very tight in flexion after cut.No further information available at the moment.
Event or Problem Description
It was reported that, during a tka surgery, the tibia cutting block of a vis adpt guide lgnp kit was off, after cut the knee was very tight in flexion.It is unknown how the procedure was completed or if there was any delay as a consequence of this problem.
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 the tibia cutting block of a vis adpt guide lgnp kit was off, after cut the knee was very tight in flexion.It is unknown how the procedure was completed or if there was any delay as a consequence of this problem.However, further clarification was attempted and no further information that stated any injury to the patient was available.Therefore, this event is not likely to cause or contribute to a death or serious injury.

• Brand Name: NS VIS ADPT GUIDE LGNP KIT
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 16746941
• Report Number: 1020279-2023-00835
• Device Sequence Number: 19649646
• Product Code: JWH
• UDI-Device Identifier: 00885556656563
• UDI-Public: 00885556656563
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K170282
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/01/2023

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: 06/26/2023
• Device Model Number: V0100109
• Device Catalogue Number: V0200109
• Device Lot Number: 00251024V1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2023
• Supplement Date Received by Manufacturer: 05/05/2023; 09/01/2023
• Initial Report FDA Received Date: 04/14/2023
• Supplement Report FDA Received Date: 05/11/2023; 09/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/28/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown