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

Model Number V0100112

Device Problems Break (1069); Fitting Problem (2183)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/25/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that, during a tka surgery a vis adpt guide kit jii the tibia cut block seemed to be fraying when the surgeon cut through it.This caused a piece of the block to fly off inside the cut slot.The 5-1 femur cutting block also did not fit very well into the pre drilled distal holes from the visionaire blocks, although the surgeon was able to make it work.Surgery was finished with the same device.Patient was not injured as consequence of this problem.

Manufacturer Narrative

H10: the device was not returned for evaluation but the pictures were reviewed, and the fraying of the cut block was confirmed, however the fitting problem could not be confirmed.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 risk management file and instructions for use documents 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.An engineering evaluation was performed and could not confirm a root cause for the stated failure modes.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.This is a single use device, damage from misuse or rough handling are likely probable causes of the reported fraying.Possible causes for the fitting problem could include but not limited to surgical technique used or user/procedural variance.The contribution of the device to the reported event could be corroborated because the device seems to be frayed, however the contribution of the device to the fitting problem could not be corroborated.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.Internal complaint reference number: (b)(4).

• Brand Name: VIS ADPT GUIDE KIT JII
• 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: 12805797
• MDR Text Key: 281085812
• Report Number: 1020279-2021-08122
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00885556656419
• UDI-Public: 00885556656419
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 06/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V0100112
• Device Catalogue Number: V0100112
• Device Lot Number: 00212886
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/02/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1