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 Patient Involvement (2645)

Event Date 06/08/2020

Event Type  malfunction  

Event Description

It was reported that the insert trial was found to be broken.As this was noticed upon inspection, no patient was involved.

Manufacturer Narrative

The device, intended for use in treatment, was returned for evaluation.A visual inspection confirms the trial a deep gouges and burrs in the plastic.The device shows significant signs of wear/usage.The device was manufactured in 2018.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.The device is a reusable instrument that can be exposed to numerous surgeries and cleaning cycles.As plastics are vulnerable and crack may have initiated 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.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.

• 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
• MDR Report Key: 10184275
• MDR Text Key: 196090278
• Report Number: 1020279-2020-02662
• 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
• Type of Report: Initial,Followup
• Report Date: 09/24/2020

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: 71436137
• Device Catalogue Number: 71436137
• Device Lot Number: 18DB01075
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/08/2020
• Initial Date FDA Received: 06/23/2020
• Supplement Dates Manufacturer Received: 09/16/2020
• Supplement Dates FDA Received: 09/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1