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

Model Number	V0100108
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference number: (b)(4).
Event or Problem Description
It was reported that during a tka, when surgeon placed the vis adpt guide lgnp tib with alignment rod.Paddles were not sitting correctly.They were not flush on the tibia plateaus.Slope appeared to be at 0 degrees when planned for 3 degrees.Instruments inside patient, procedure finished with same device.Surgical delay of less than or equal to 30 minutes.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
Expiration date added manufacture date added the device was not returned for evaluation but the pictures were reviewed, and they confirm that the tibial slope was not as planned.The clinical/medical investigation concluded that, based on the limited information provided, the root cause of the reported events cannot be definitively concluded, however, user technique cannot be ruled out as a contributing factor or if the plan would have been changed if reviewed prior to auto approval.The patient impact beyond the reported slope inaccuracy and surgical delay cannot be determined ,as it was not reported how this affected the rom or patient ambulation, although based on the x-ray, it could be possible that it reduced extension of the tibia.The patient¿s current health status is unknown and no further clinical medical assessment can be rendered.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 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.An engineering evaluation was performed and could not confirm a root cause for the stated failure mode.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible causes could include but not limited to surgical technique used 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.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.Case (b)(4) lot number updated.

• Brand Name: VIS ADPT GUIDE LGNP TIB
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/
• 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: 11479249
• Report Number: 1020279-2021-02129
• Device Sequence Number: 14358834
• Product Code: JWH
• UDI-Device Identifier: 00885556656389
• UDI-Public: 00885556656389
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2022

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: 06/01/2021
• Device Model Number: V0100108
• Device Catalogue Number: V0100108
• Device Lot Number: 00191456V1
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2021
• Supplement Date Received by Manufacturer: 03/17/2022
• Initial Report FDA Received Date: 03/15/2021
• Supplement Report FDA Received Date: 03/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/03/2020
• 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