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

Catalog Number V0200112

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

Patient Problem Laceration(s) (1946)

Event Date 08/09/2023

Event Type  Injury  

Manufacturer Narrative

H10: internal complaint reference: (b)(4).

Event Description

It was reported that during a tka surgery, using the ns vis adpt guide jii kit, the tibia resection was planned for 10mm on the high side but after putting the block on the patient and pinning it in place, the surgeon cut through the metal tibia cut block but did not cut through the visionaire block.The surgeon cut off the top of the metal tibia cut block, rather than the cutting slot, because the resection looked too large.A 12mm poly was still used.The resection amount was much larger than what the visionaire plan indicated.In addition, the size five femur was far too big.They did not take any of the anterior femur with the size five cut block, through the anterior cutting slot.Needed to downsize to a four femur immediately.The procedure was resumed after a non-significant delay.Additional anesthesia was not required.Patient is recovering.No further information is available and no further complications were reported.

Manufacturer Narrative

H3, h6: the device was not returned for evaluation; therefore, a device analysis could not be performed.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.However, by means of an engineering evaluation, our team found that the alignment engineer did not follow the surgeon's preference in the planning of the case.The femur preference to downsize should have been followed.Additionally, the surgeon's preference for varus cases is a 10 mm tibia resection.The patient's small anatomy and higher medial plateau should be taken into consideration to reduce the resection.The engineer was made aware of the errors with this case.A review of complaint history revealed similar events for the listed device over the previous 12 months.Visionare devices are patient-matched, therefore, no additional review was performed for the batch based on the historical data; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the instructions for use documents for visionare patient matched instrumentation with fastpak instruments revealed that if the patient matched cutting block 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.The clinical/medical investigation concluded that, based on the information provided in the engineering evaluation, it did confirm a human error caused the reported adverse event.There were no clinical factors identified which would have caused or contributed to the reported event.According to the report, the surgeon completed the procedure after a non-significant delay without additional anesthesia.It is unknown if the patient would require further interventions in the future due to the required 12 mm insert, smaller than planned femur.Since it was reported the patient is recovering, the patient impact beyond that which has already been reported cannot be determined based on the information provided.Should any additional relevant medical information be provided, this case would be re-assessed.At this time, we do have reason to suspect that the product failed to meet specifications at the time of manufacture.The root cause of this event was determined to be that the case was incorrectly aligned by internal visionaire employee.Since this failure mode rate is within the anticipated acceptable risk limit, 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 JII KIT
• Type of Device: 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: 17684469
• MDR Text Key: 322654278
• Report Number: 1020279-2023-01724
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00885556658406
• UDI-Public: 885556658406
• 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
• Report Date: 10/12/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 01/23/2024
• Device Catalogue Number: V0200112
• Device Lot Number: 00263095V1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/16/2023
• Initial Date FDA Received: 09/05/2023
• Supplement Dates Manufacturer Received: 10/11/2023
• Supplement Dates FDA Received: 10/12/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/27/2023
• 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