MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY FEM IMPACT BUMPER LT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number 74012821

Device Problems Crack (1135); Component Missing (2306)

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

Event Date 05/24/2021

Event Type  malfunction  

Event Description

It was reported that, during surgery, it was noticed that a journey fem impact bumper lt ((b)(4)) had a piece missing a lug on bottom and cracked.The grooves that slide onto the jrny ii tka fem trial sz 3 lt ((b)(4)) were stripped and it did not load properly, and also a journey art isrt assm tool ((b)(4)) had no tension and did not work to seat poly.Devices outside the patient.The procedure was completed without delay using a s+n back up devices.Patient was not harmed.

Manufacturer Narrative

H3, h6: the associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device has a crack in the middle and missing a tab, rendering the device inoperative.The device shows signs of extensive use.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed for any necessary corrective actions.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.This device is a reusable instrument that can be exposed to numerous surgeries.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.Based on this investigation, the need for corrective action is not indicated.Should 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: JOURNEY FEM IMPACT BUMPER LT
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11942547
• MDR Text Key: 254538724
• Report Number: 1020279-2021-05013
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 03596010556899
• UDI-Public: 03596010556899
• 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: 07/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 74012821
• Device Catalogue Number: 74012821
• Device Lot Number: 13FM06668
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2021
• Date Manufacturer Received: 07/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1