MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II UNI RESECT AP BLOCK RM/LL SZ 5; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 74016415

Device Problem Defective Device (2588)

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

Event Date 02/02/2021

Event Type  malfunction  

Manufacturer Narrative

the device, used in treatment was returned for evaluation: a visual inspection was performed and confirmed the device has discoloration in the metal and moderate signs of wear/usage.The middle hole of the device appear to be chipped on the edges, which may cause it to not function as intended.The manufactured date for this device is 2019.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed

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Event Description

It was reported that, during a tka procedure, while using a jrny ii uni resect ap block rm/ll sz 5 outside the patient, the middle hole would no long allow t-handle attachment and it needs to be returned and replaced.The procedure was successfully completed without delay using a smith+nephew back-up device.No patient injury or other complications were reported.

Manufacturer Narrative

The device, used in treatment was returned for evaluation: a visual inspection was performed and confirmed the device has discoloration in the metal and moderate signs of wear/usage.The middle hole of the device appear to be chipped on the edges, which may cause it to not function as intended.The manufactured date for this device is 2019.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: JRNY II UNI RESECT AP BLOCK RM/LL SZ 5
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11572435
• MDR Text Key: 242377259
• Report Number: 1020279-2021-02381
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 00885556690062
• UDI-Public: 00885556690062
• Combination Product (y/n): N
• PMA/PMN Number: K190085
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 74016415
• Device Catalogue Number: 74016415
• Device Lot Number: 19JM09561
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1