MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY UNI TIB TR INS SZ 1-2/9MM; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	71436129
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during an unknown surgery, a piece of plastic of one journey uni tib tr ins sz 1-2/9mm broke.The broken piece of plastic was located and removed.Surgery was resumed, without any delay, with the same device.No health consequences were reported.
Additional Manufacturer Narrative
The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device was fractured along the lasered surface, rendering the device inoperative.All of the broken components were returned.The device shows signs of extensive use.A review of complaint history did not reveal additional complaints for the listed batch.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.A review of the risk management file revealed this failure mode was previously identified.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are 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 future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: JOURNEY UNI TIB TR INS SZ 1-2/9MM
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12320841
• Report Number: 1020279-2021-06362
• Device Sequence Number: 4136710
• Product Code: HSX
• UDI-Device Identifier: 03596010588074
• UDI-Public: 03596010588074
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71436129
• Device Catalogue Number: 71436129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2021
• Initial Date Received by Manufacturer: 08/02/2021
• Supplement Date Received by Manufacturer: 09/13/2021
• Initial Report FDA Received Date: 08/13/2021
• Supplement Report FDA Received Date: 09/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention