MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY UNI TIB TR INS SZ3-4/8MM; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	71436133
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/14/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure ukr (navio), the bottom corner of the plastic of the insert was snapped off outside the patient, after the surgeon attempted to mount into the trial.The procedure was completed without delay.Patient injuries were not reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
It was reported that during the procedure ukr (navio), the bottom corner of the plastic of the insert was snapped off outside the patient, after the surgeon attempted to mount into the trial.The procedure was completed without delay.The affected complaint device, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.A photo attached to the complaint confirms that a piece of the device is broken off.The broken piece is not shown in the photo.As lot information was not made available, device history record review cannot be completed.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.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.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: JOURNEY UNI TIB TR INS SZ3-4/8MM
• 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: 10387937
• Report Number: 1020279-2020-03820
• Device Sequence Number: 3669183
• Product Code: HSX
• UDI-Device Identifier: 03596010588104
• UDI-Public: 03596010588104
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K113038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2021

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
• Operator of Device: Health Professional
• Device Model Number: 71436133
• Device Catalogue Number: 71436133
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/14/2020
• Supplement Date Received by Manufacturer: 03/23/2021
• Initial Report FDA Received Date: 08/10/2020
• Supplement Report FDA Received Date: 04/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1