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

Model Number	V0200109
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during a tka surgery, the femur and tibia guides from a ns vis adpt guide lgnp kit were airballed when fitting blocks.The surgeon had to recut both distal femur and proximal tibia.An additional 2mm were resected on the femur and an additional 4mm on the tibia.Surgery was resumed, with a change in surgical technique.It is unknown if there was any delay.Patient was not harmed beyond the reported problem.
Additional Manufacturer Narrative
Internal complaint reference: case (b)(4).
Additional Manufacturer Narrative
H3, h6.The device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, per complaint details, the visionaire guides ¿were airballed when fitting blocks ¿ and resulted in the need for the surgeon to resect an additional 2mm from distal femur and an additional 4mm from the proximal tibia.Reportedly, the procedure resumed using a change in surgical technique without patient injury.It is unknown if a surgical delay resulted.Further clinical documentation has not been provided as of the date of this medical assessment.The visionaire¿ surgical technique does recommend use of back-up instrumentation should the adaptive guide be determined unsuitable for its intended use.Based on the information provided, the clinical root cause could not be definitively concluded.Further patient impact would not be anticipated as the surgeon reportedly completed the procedure with a change of surgical technique and no patient injury was alleged.Based on this information, no further medical assessment is warranted at this time.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 instructions for use documents for visionaire revealed that if the patient matched cutting guide or fastpack instrument does not perform as intended, use the standard smith & nephew instrumentation to complete the surgery has been identified as device description.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.According with inspection drawing, part number, size, implant type, hand, recut type, saw blade thickness and part configuration should be verified, it also has to be verified that the part should be free of burrs, damaged areas and sharp edges, besides dimensions should be measured with caliper to ensure print specifications.An assessment made by a quality engineer was performed and could not confirm a root cause for the stated failure mode.All checks were found to be within visionaire standards.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes for this event could include a fit/ sizing issue or user/procedural variance.The contribution of the device to the reported event could not be corroborated.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.We consider this investigation closed.

• 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: 13636326
• Report Number: 1020279-2022-00939
• Device Sequence Number: 13984456
• Product Code: JWH
• UDI-Device Identifier: 00885556656563
• UDI-Public: 00885556656563
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: V0200109
• Device Catalogue Number: V0200109
• Device Lot Number: 00221525
• 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: 02/09/2022
• Supplement Date Received by Manufacturer: 09/02/2022
• Initial Report FDA Received Date: 03/01/2022
• Supplement Report FDA Received Date: 09/05/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown