MAUDE Adverse Event Report: SMITH & NEPHEW, INC. NS VIS ADPT GUIDE JII KIT; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAINED,CEMENTED,POLYMERMETALPOLYMER

Model Number V0200112

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problems Rupture (2208); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/15/2021

Event Type  Injury  

Event Description

It was reported that during tka with ns vis adpt guide jii kit, the staff needed to be taking a big cut on the tibia 2mm, they went down at least 4mm.The distal femur was also very minimal and they had to take an extra 2mm with normal cutting block.Further information is unknown at the moment.

Manufacturer Narrative

Internal complaint reference (b)(4).

Manufacturer Narrative

Section h3, h6: the device was not returned for evaluation.However, the event could be confirmed with the findings of our internal quality process.The clinical/medical investigation concluded that, per case details, during total knee arthroplasty surgery, the staff planned a 2mm cut of the tibia and went down at least 4mm.Reportedly, an extra 2mm was taken with the normal cutting block, due to ¿implant would be too tight without the extra 2mm of bone respected,¿ (resected).The procedure was completed with an ¿smith and nephew implant and conventional cutting block to adjust cut,¿ and there was surgical delay of ¿15mins max to adjust cut a little.¿ per email communication, the patient¿s current health status is ¿doing well¿ and the surgeon reportedly does not anticipate further medical/surgical intervention due to the reported events.Based on the information provided, the root cause of the reported events could not be definitively concluded.No patient impact beyond the reported events is anticipated, no patient injury has been alleged and the surgeon was reportedly, satisfied with the surgical outcome.Therefore, no further medical assessment is warranted.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 file is not applicable for this instrument.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 to the 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.A review made by the quality engineering team did confirm a potential root cause for the stated failure mode.The evaluation found that the alignment engineer over segmented the sulcus region of the femur.This resulted in a sulcus resection less than required by the surgeon's preference.The root cause of the complaint however was not determined.The proximal resection was limited to no more than 9mm which followed the surgeon's preference.The engineer team was made aware of the issue determined within the segmentation.At this time, we do have reason to suspect that the product failed to meet product specifications at the time of manufacture.The root cause of this event was determined to be that the alignment engineer over segmented the sulcus region of the femur.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.B1: adverse event and/or product problem and b2: outcomes attributed to adverse event h6: health effect - clinical code and health effect - impact code.

• Brand Name: NS VIS ADPT GUIDE JII KIT
• Type of Device: PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAINED,CEMENTED,POLYMERMETALPOLYMER
• 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: 13191708
• MDR Text Key: 283402179
• Report Number: 1020279-2022-00113
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00885556658406
• UDI-Public: 00885556658406
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/18/2021
• Device Model Number: V0200112
• Device Catalogue Number: V0200112
• Device Lot Number: 00214314V1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2021
• 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): Hospitalization; Required Intervention