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	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during a tka surgery, the cutting slots of a non sterile visionaire adaptive guide kit legion primary were not fully open, a blade couldn¿t pass through them, on both femur and tibia cutting blocks, it was needed to slide the metal blocks over the pins to make the cuts.Also, the femur cutting block did not contact bone distal lateral and anterior lateral, so the surgeon had to recut using mechanical instruments.Added, the tibial cutting block had great contact but cut the tibia in about 2 degrees of valgus., so manual instruments had to be used to correct this issue.Surgery was completed, after a non-significant delay, by changing the surgical technique.Patient was not injured as consequence of this problem, even though, the surgeon stated that this may be potentially affecting the long term outcome of this patient.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H3, h6: the associated device was returned and evaluated.A visual inspection of the returned blocks confirmed the failure mode of the cutting slots not being fully open.The slots had signs of burrs from attempted use.The slots would not accept the manufacturing gage across the full range of the slot.The slots appeared to be deformed/ bowed.The slots are inspected 100% by the operator during manufacturing.Additionally, an engineering evaluation was performed and did confirm a potential root cause for the stated failure mode of femoral block fit.The clinical/medical evaluation concluded that without the requested documentation/information, the clinical root cause of the reported block issues including the inability to pass the blade through the guide, inaccurate block fit, and resulting valgus cuts could not be definitively concluded.The patient impact beyond the reported initial valgus cuts and use of manual instrumentation/change in surgical technique to complete the procedure within a ¿non-significant¿ surgical delay cannot be determined.The current patient status remains unknown, and no determination could be made regarding the surgeon statement ¿that this may be potentially affecting the long-term outcome of this patient¿, as reportedly the issues were corrected via manual instrumentation and the procedure concluded ¿without significant delay¿ and the patient was ¿not injured as a consequence¿.No further medical assessment can be rendered at this time.The manual instrumentation is an approved surgical technique for these implants.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 have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use document revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.A contribution of the device to the reported event could be corroborated since the slots were not fully open and the femur cutting block didn't fit, requiring a change to manual instrumentation.A potential probable cause could be but is not limited to an error in the segmentation process (under-segmentation) or an issue with the cutting slot.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 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: 13353113
• Report Number: 1020279-2022-00311
• Device Sequence Number: 4646255
• Product Code: JWH
• UDI-Device Identifier: 00885556656563
• UDI-Public: 00885556656563
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 09/20/2022

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: 00222342
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2022
• Supplement Date Received by Manufacturer: 09/16/2022
• Initial Report FDA Received Date: 01/25/2022
• Supplement Report FDA Received Date: 09/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Other
• Patient Sex: Unknown