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

Model Number	V0100082
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a tka surgery, the vis cut guide jii kit lt pinholes incorporated were incorrect.Surgeon was unable to use the guides due to japan regulations.Surgery was resumed, without any delay, with the same device.Patient was not harmed.No further complications reported.
Additional Manufacturer Narrative
Internal complaint reference: case(b)(4).
Additional 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.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 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 revealed that the engineer performing the alignment task failed to turn off the universal kit expression.Doing this adjusts the pin hole alignment to the recut guide thus the reason for the complaint.The quality team was notified of the issue so this doesn't reoccur.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 engineer performing the alignment task failed to turn off the universal kit expression.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.B5: describe event or problem.
Event or Problem Description
It was reported that, during a tka surgery, the vis cut guide jii kit lt pinholes incorporated were incorrect.Surgeon was unable to use the guides due to japan regulations.Surgery was resumed, without any delay.Patient was not harmed.No further complications reported.

• Brand Name: VIS CUT GUIDE JII KIT LT
• 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: 14141722
• Report Number: 1020279-2022-01855
• Device Sequence Number: 17202913
• Product Code: JWH
• UDI-Device Identifier: 00885556492680
• UDI-Public: 00885556492680
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K082358
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: V0100082
• Device Catalogue Number: V0100082
• Device Lot Number: 00227055
• 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: 03/24/2022
• Supplement Date Received by Manufacturer: 01/25/2023
• Initial Report FDA Received Date: 04/19/2022
• Supplement Report FDA Received Date: 02/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Unknown