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

Model Number	V0100109
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: case (b)(4).
Event or Problem Description
It was reported that, while using vis adpt guide lgnp kit during a tka, the tibial guide had too much varus built in.Surgeon had to use standard instrumentation to make proximal tibial cut.It is unknown how long surgery was delayed as consequence.On the other hand, the femoral guide was fine and resulted in a good cut.Patient was not harmed.
Event or Problem Description
It was reported that, while using vis adpt guide lgnp kit during a tka, the tibial guide had too much varus built in.Surgeon had to use standard instrumentation to make proximal tibial cut.It is unknown how long surgery was delayed as consequence.On the other hand, the femoral guide was fine and resulted in a good cut.Patient was not harmed.
Additional Manufacturer Narrative
Internal complaint reference: case (b)(4).
Additional Manufacturer Narrative
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 tibial guide had too much varus built in; therefore, the surgeon had to use standard instrumentation to make proximal tibial cut resulting in additional, unintended tibial bone resection as well as a slight (5 min) surgical delay.It was communicated that the requested clinical documentation was not available due to protected health information.Reportedly, the patient was not harmed beyond the reported event.Based on the information provided, the clinical root cause cannot be definitively concluded and the patient impact beyond that which was reported can not be determined.No further medical assessment is warranted at this time.A review of the production order 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.A historical review concluded that there are no prior actions related to this product and event.This event was evaluated through our internal quality process and it was concluded that the root cause cannot be confirmed.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.This is a single use device, surgical technique or damage from misuse are likely potential factors that could contribute to the reported event.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.
Event or Problem Description
It was reported that, while using vis adpt guide lgnp kit during a tka, the tibial guide had too much varus built in.Surgeon had to use standard instrumentation to make proximal tibial cut.Surgery was delayed 5 min as consequence and resulted in additional, unintended resected bone.On the other hand, the femoral guide was fine and resulted in a good cut.The patient was not harmed beyond the described event.
Additional Manufacturer Narrative
Internal reference number: (b)(4).

• Brand Name: 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: 13587163
• Report Number: 1020279-2022-00822
• Device Sequence Number: 4410119
• Product Code: JWH
• UDI-Device Identifier: 00885556656396
• UDI-Public: 00885556656396
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,Followup
• Report Date (Section B): 10/10/2022

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 Expiration Date: 06/26/2022
• Device Model Number: V0100109
• Device Catalogue Number: V0100109
• Device Lot Number: 00221836V1
• 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: 02/03/2022
• Supplement Date Received by Manufacturer: 02/24/2022; 10/07/2022
• Initial Report FDA Received Date: 02/23/2022
• Supplement Report FDA Received Date: 02/25/2022; 10/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/28/2021
• 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 Age: 71 YR
• Patient Sex: Female