MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY UNI TRAY 2; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Catalog Number	71422379
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/05/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during surgery, when opening the instruments trays; from 3 trays that the surgeon had available, 2 were duplicates; causing a delay greater than 30 minutes and forcing the surgeon to change the original procedure to continue with the surgery.
Additional Manufacturer Narrative
The associated device was not returned.A clinical analysis indicated that it was reported that a procedural delay of 1-2 hours occurred as a result of a device related issue.A total knee replacement was performed (using a competitor implant) rather than the planned uni procedure.There is no relevant supporting patient clinical information provided, and there is no report of the patient's current condition.Therefore, no further clinical assessment is warranted at this time.This issue has been submitted to our capa process in accordance with applicable internal capa procedures.Should additional information be received, the complaint will be reopened.We consider this investigation closed.Credit will be issued for the device.
Additional Manufacturer Narrative
The associated device was not returned.A review of the provided photos indicated that an incorrect tray was sent for a surgery requiring 3 different trays, confirming the stated complaint.A clinical analysis indicated that it was reported that a procedural delay of 1-2 hours occurred as a result of a device related issue.A total knee replacement was performed (using a competitor implant) rather than the planned uni procedure.There is no relevant supporting patient clinical information provided, and there is no report of the patient's current condition.Therefore, no further clinical assessment is warranted at this time.This distribution issue has been submitted to our capa process in accordance with applicable internal capa procedures.An awareness to be provided to all logistics had been made aware of this non-conformance and seriousness of the issue.As a result of the capa process, corrective actions are being implanted to improve our process, making it more robust to help reduce/eliminate this issue from recurrence.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: JOURNEY UNI TRAY 2
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7652318
• Report Number: 1020279-2018-01237
• Device Sequence Number: 19221258
• Product Code: MDM
• UDI-Device Identifier: 03596010626844
• UDI-Public: 03596010626844
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/31/2018

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 71422379
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/11/2018
• Supplement Date Received by Manufacturer: 06/11/2018; 06/11/2018
• Initial Report FDA Received Date: 06/29/2018
• Supplement Report FDA Received Date: 09/14/2018; 10/31/2018
• 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: Other