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	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	03/29/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during a tka, while utilizing an ns vis adpt guide lgnp kit, an 15mm insert was used as a consequence of excessive tibia resection.Surgery was resumed, without any delay, with the same device.No further complications were reported.
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, of note, no response/clarification or supporting clinical documentation has been provided as of the date of this medical investigation; therefore, no clinical factors have been identified which would have contributed to the reported event.The patient impact beyond the reported use of a 15mm insert cannot be determined as it is unknown if the native joint line was maintained or if it may increase the risks for future knee joint interventions.No further medical assessment can be rendered at this time.Device batch number was not provided, thus, an evaluation of the manufacturing records could not be performed.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 in the device description that the surgical technique brochure shall be referred for complete procedural information and, if the patient matched cutting guide or fastpak instrument 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.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 or user/procedural variance.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: 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: 16791779
• Report Number: 1020279-2023-00899
• Device Sequence Number: 5695198
• Product Code: JWH
• UDI-Device Identifier: 00885556656563
• UDI-Public: 00885556656563
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: V0200109
• Device Catalogue Number: V0200109
• Device Lot Number: UNKNOWN
• 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: 03/29/2023
• Supplement Date Received by Manufacturer: 05/23/2023
• Initial Report FDA Received Date: 04/21/2023
• Supplement Report FDA Received Date: 05/24/2023
• 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 Sex: Unknown