MAUDE Adverse Event Report: SMITH & NEPHEW, INC. VIS ADPT GUIDE JII FEM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Model Number	V0100110
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during tka surgery, when the surgeon was making distal femoral resection through visionaire adaptive guide distal femur journey ii, the block split in two while was inside the patient.The procedure was finished using the same device, without surgical delay and no injury to the patient.
Additional Manufacturer Narrative
The associated device, used in treatment, was not returned for evaluation.A review of the attached pictures confirmed the stated failure mode.The device fractured at the cutting slot.The clinical medical investigation concluded that ,although responses to the documentation/information requests were not provided, per the case details, the procedure was completed with the same device without patient harm or delay.Without the requested information, no further medical assessment could be rendered at this time.The root cause could not be concluded and the patient impact beyond the removal of the broken block could not be determined, although reportedly no patient injury or surgical delay resulted.Should clinically relevant documentation become available, the medical investigation task may be re-evaluated.A review of complaint history did not reveal additional complaints for the listed device for the same failure mode.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 have no 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 documents revealed this failure mode was previously identified.Some potential probable causes for this event could include transit damage or a procedural variance.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.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: VIS ADPT GUIDE JII FEM
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11687116
• Report Number: 1020279-2021-03195
• Device Sequence Number: 2936232
• Product Code: JWH
• UDI-Device Identifier: 00885556656402
• UDI-Public: 00885556656402
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K170282
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2021

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: V0100110
• Device Catalogue Number: V0100110
• Device Lot Number: 00196704V1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/24/2021
• Supplement Date Received by Manufacturer: 10/10/2021
• Initial Report FDA Received Date: 04/19/2021
• Supplement Report FDA Received Date: 10/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention