MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS ART ISRT TRL SZ 3-4 9MM LT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number 74035241

Device Problem Incomplete or Inadequate Connection (4037)

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

Event Date 06/09/2021

Event Type  malfunction  

Event Description

It was reported that, during set up for a tka surgery, a jrny ii bcs art insert trial sz 3-4 9mm lt ((b)(4)) did not sit flush while trialing.It was also reported that a gii p/s cons housing ream dome ((b)(4)) was noticed to be dull.No significant surgical delay occurred due to this event, but it is unknown how was the procedure concluded.No patient injury was reported due to these events.

Manufacturer Narrative

H3, h6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.A complaint history review found related failures for the listed device; this failure mode will be monitored for future complaints for any necessary corrective actions.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.The device is a reusable instrument that can be exposed to numerous surgeries and cleaning cycles.As plastics are vulnerable, damage may occur during use and possible causes could be due to the heating and cooling associated with autoclaving or prolonged use.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.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: JRNY II BCS ART ISRT TRL SZ 3-4 9MM LT
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12053612
• MDR Text Key: 258151755
• Report Number: 1020279-2021-05385
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00885556156889
• UDI-Public: 00885556156889
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 08/05/2021

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
• Device Operator: Health Professional
• Device Model Number: 74035241
• Device Catalogue Number: 74035241
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/09/2021
• Initial Date FDA Received: 06/23/2021
• Supplement Dates Manufacturer Received: 08/04/2021
• Supplement Dates FDA Received: 08/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1