MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY UNI TIB TR INS SZ5-6/8MM; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 71436137

Device Problem Break (1069)

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

Event Date 03/05/2021

Event Type  malfunction  

Event Description

It was reported that during an inspection in the warehouse it was noticed the failure of defective devices.The journey ii bcs articular insert size 1-2 9 mm left ((b)(4)), the journey ii bcs articular insert size 1-2 9 mm right ((b)(4)), two universal insert spacer size 1-2 18 mm ((b)(4)), journey ii cr locking femoral impactor bumper right ((b)(4)), journey uni tibia insert size 1-2/8 mm ((b)(4)), journey uni tibia trial size 5-6/8 mm ((b)(4)), journey uni tibia trial size 3-4/8 mm ((b)(4)), three honeycomb ((b)(4)), journey ii bcs articular insert trial size 1-2 10 mm right ((b)(4)), the journey ii bcs articular insert trial size 1-2 10 mm left ((b)(4)) and the journey ii bcs articular insert trial size 1-2 12 mm left ((b)(4)) were noticed cracked.Two compression screw hex driver ((b)(4)) and screwdriver release handle ((b)(4)) were noticed broken.No case involved.

Manufacturer Narrative

The device, intended for use in treatment, was not returned for evaluation.Therefore, the product analysis and the reported event could not be confirmed at this time.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 complaint history on the listed part revealed no prior complaints for the listed failure mode with the same batch number.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.A relationship between the device and the reported incident is not corroborated.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.

Event Description

It was reported that during an inspection in the warehouse it was noticed the failure of journey uni tibia trial size 5-6/8 mm.No case involved.

• Brand Name: JOURNEY UNI TIB TR INS SZ5-6/8MM
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116 ; UK 38116
• MDR Report Key: 11593434
• MDR Text Key: 244911831
• Report Number: 1020279-2021-02541
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 03596010588142
• UDI-Public: 03596010588142
• Combination Product (y/n): N
• PMA/PMN Number: K113038
• 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: 05/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71436137
• Device Catalogue Number: 71436137
• Device Lot Number: 18DB01075
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1