MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN VISIONAIRE CUT GUIDE INSTR; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	V0200109
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	09/12/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during a tka, using an unkn visionaire cut guide instr for legion primary cr tka surgery caused notching during the anterior resection due to the engineer¿s alignment.The procedure was resumed, after a non significant delay, with a change in surgical technique.No other complications were reported.Patient is healthy and recovering normally from surgery.
Additional Manufacturer Narrative
The device was not returned for evaluation.However, the provided x-ray was analyzed by the clinical/medical team and appears to show an intact right total knee arthroplasty, with obvious anterior femoral notching.Also, the clinical/medical investigation concluded that, reportedly, the anterior notching was ¿due to engineer¿s alignment¿.Based on the documentation provided, no clinical factors have been identified which would have contributed to the reported event.The assessed patient impact includes the anterior notching, the reported slight (0-30 minute) surgical delay, and the anticipated post-operative rehabilitative phase.Although controversial, anterior notching has been associated with a possible increased risk for periprosthetic fractures and early revision; however, this cannot be concluded.Per correspondence, the patient is healthy and recovering normally.Further patient impact cannot be determined.No further medical assessment can be rendered 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.As visionaire devices are custom made devices, a review of the complaint history for this part is not applicable.A review of the instructions for use documents for visionaire¿ patient matched instrumentation with fastpak instruments revealed that if the patient matched cutting guide does not perform as intended, use the standard smith & nephew instrumentation to complete the surgery.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.A review made by the quality engineering team revealed that after a thorough review of the device standards, the engineering team could not determine a root cause for the complaint.All parts of the designed device were within the visionaire standards.At this time, we have no reason to suspect that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include surgical technique used, user/procedural variance or segmentation error.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.We consider this investigation closed.

• Brand Name: UNKN VISIONAIRE CUT GUIDE INSTR
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/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: 15535490
• Report Number: 1020279-2022-04278
• Device Sequence Number: 8133481
• Product Code: HSX
• UDI-Device Identifier: 00885556656563
• UDI-Public: 00885556656563
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• 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): 06/02/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: V0200109
• 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: 09/12/2022
• Supplement Date Received by Manufacturer: 05/31/2023
• Initial Report FDA Received Date: 10/04/2022
• Supplement Report FDA Received Date: 06/02/2023
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown