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

Catalog Number V0200112

Device Problem Nonstandard Device (1420)

Patient Problems Perforation (2001); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/08/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the tibial component was undersized and the surgeon went with a size 3.The surgeon would rather be at the cortex than undersized as this is happening quite often.The surgeon pinned the 3 with the holes from the visionaire block it left the component posterior and had to be repositioned and re-drill holes to secure the trial on the anterior cortex.No further information was provided.

Manufacturer Narrative

The device, used for treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So the reported event could not be confirmed.A medical investigation was conducted and confirms per complaint details, the tibial component was undersized; therefore, the surgeon had to reposition the visionaries block and re-drill holes to secure the trial onto the anterior cortex for a size 3, as the block had left the component posterior.Responses to medical documentation requests had not been received as of the date of this assessment.Patient impact beyond the reported modified surgical procedure with re-drilled bone holes could not be determined.The patient and surgical outcome was not provided.No further medical assessment could be rendered at this time.Should clinically relevant documentation/information and/or the engineering evaluation results become available, the clinical/medical task may be re-evaluated.Possible probable cause could include but not limited the user error.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

Event Description

It was reported that during a visionarie case, the tibial component of the patient was undersized and the surgeon went with a size 3.The surgeon pinned the 3 with the holes from the visionaire block it left the component posterior and had to be repositioned and re-drill holes to secure the trial on the anterior cortex.No further information was provided.It is unknown the condition of the patient.

Manufacturer Narrative

Additional information: d4.H3, h6: the device was not returned for evaluation but the reported event could be confirmed according to the engineering evaluation.The clinical/medical investigation concluded that, per complaint details, the tibial component was undersized; therefore, the surgeon had to reposition the visionaire block and re-drill holes to secure the trial onto the anterior cortex for a size 3, as the block had left the component posterior.Responses to medical documentation requests had not been received as of the date of this assessment.The engineering evaluation confirmed an undersized tibia with difference in pin hole alignment when upsizing as a potential root cause for the stated failure mode.Patient impact beyond the reported modified surgical procedure with re-drilled bone holes could not be determined.The patient and surgical outcomes were not provided.No further medical assessment could be rendered at this time.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of the instructions for use documents for visionaire revealed that if the patient matched cutting guide or fastpack instrument does not perform as intended, use the standard smith & nephew instrumentation to complete the surgery have been identified as device description.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.According with inspection drawing, part number, size, implant type, hand, recut type, saw blade thickness and part configuration should be verified, besides dimensions should be measured with caliper to ensure print specifications.An assessment made by a quality engineer was performed and did confirm a potential root cause for the stated failure mode.The evaluation found that the alignment engineer undersized the tibia and did not follow the surgeon's preference to upsize.Since the size 3 was selected over the planned size 2, the pinholes created with the visionaire block would not line up with the size 3 trial correctly for positioning, as pinholes on the trials shift when going from a size 2 to a size 3.Based on this investigation, the need for corrective action is not indicated as the failure mode rate is within the anticipated acceptable risk limit in the risk management plan.At this time, we do have reason to suspect that the product failed to meet product specifications at the time of manufacture.Possible causes could include an error during manufacturing process, downsizing the dimension of the device.The contribution of the device to the reported event could be corroborated due to errors during manufacturing process, generating to re-drill on the anterior cortex.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.H6, h10.

• Brand Name: NS VIS ADPT GUIDE JII KIT
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CNSTRND, CEMENTED, POLY/METAL/POLY
• 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: 11113897
• MDR Text Key: 225033258
• Report Number: 1020279-2021-00068
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170282
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/26/2021
• Device Catalogue Number: V0200112
• Device Lot Number: 00190773V1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention