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

Model Number	V0200111
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during tka surgery, a ns vis adpt guide jii tib tibial adaptive guide was noticed to have a negative slope on it.The procedure was concluded using a smith and nephew backup device, and no significant delay in surgery occurred due to this event.Neither patient injury nor other complications were reported.
Additional Manufacturer Narrative
The associated device, used in treatment, was returned for evaluation.A visual inspection of the returned device could not confirm the stated failure mode.The device shows signs of attempted use.The engineering evaluation confirmed the stated failure mode.The evaluation determined that there was under segmentation on the anterior medial tibia and over segmentation on the proximal tibia which may have caused the block to fit incorrectly.The engineer and segmenter were retrained by the segmentation subject matter expert.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.The potential probable causes for this event is likely a design error.Based on this investigation, the need for corrective action is not indicated.Should 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 JII TIB
• 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: 11907585
• Report Number: 1020279-2021-04816
• Device Sequence Number: 4381194
• Product Code: JWH
• UDI-Device Identifier: 00885556656587
• UDI-Public: 00885556656587
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2021

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 Model Number: V0200111
• Device Catalogue Number: V0200111
• Device Lot Number: 00200391V2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2021
• Initial Date Received by Manufacturer: 05/12/2021
• Supplement Date Received by Manufacturer: 10/07/2021
• Initial Report FDA Received Date: 05/31/2021
• Supplement Report FDA Received Date: 10/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1