MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ASC SET JOURNEY II BCS UNIVERSAL; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Catalog Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/14/2018

Event Type  malfunction  

Event Description

It was reported that left instruments but the right implants out went sent out.Delay over 2 hours reported.No backup available.

Manufacturer Narrative

The associated complaint device was not returned.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

Manufacturer Narrative

The associated complaint device was not returned.It was reported that smith and nephew sent the incorrect device to the hospital who consecutively missed to double-check the materials before the surgery started.Thus the failure is not product related complaint but rather it was analyzed and considered as a human error in both occasions.The error occurred at the smith and nephew warehouse for shipping the incorrect part and again at the hospital for not checking the materials before use in surgery.No further investigation is warranted for this complaint; however, smith and nephew will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, this complaint will be reopened and reevaluated.

Manufacturer Narrative

This complaint indicates that the left instruments and the right implants were sent out to the hospital for a surgery.A procedural delay of over 2 hours was reported as no backup devices were available.Review of the pick list for the scheduled surgery on (b)(6) 2018 consisted of implants only.No instruments were sent by gdc baar nor were they requested.The order was sent out of gdc baar on 11/12 /18.This order contained loan sets with implants only (right side) and sawblades.The delivery was confirmed to not contain any instruments.The shipment contained just 5 boxes.Had instruments been part of the shipment it would have contained 12/13 boxes.Further review into the event identified that on (b)(6) 2018 (b)(6) had a left knee surgery using journey ii implants.The instrument set that was supplied and was left at the hospital in anticipation of the pending surgery.The surgery scheduled for 11/14 was for a right knee.Therefore, the loaner implants which were left versions at the hospital were exchanged with right versions.In this process, it was missed to replace as well the trial sets with the right version instruments.It was detected prior to the surgery and the smith & nephew representative organized a search for another right version trial set from another hospital in the proximity, which caused about 2 hour delay to the procedure.The patient was identified to neither be in the or under anesthesia during that time, the surgery was just pushed back and another patient went into the or first.Although reported as a surgical delay there was no delay of the procedure in the sense that would make this event a reportable event.Our conclusion is that the implants were not mixed up with the wrong instruments.A review of the outbound internal loaner checklist confirms that no instruments were shipped.The claim that smith and nephew delivered the wrong instrumentation is inaccurate.

• Brand Name: ASC SET JOURNEY II BCS UNIVERSAL
• Type of Device: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8145947
• MDR Text Key: 129753125
• Report Number: 1020279-2018-02717
• Device Sequence Number: 1
• Product Code: MDM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/14/2018
• Patient Sequence Number: 1