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

Lot Number UNKNOWN

Device Problems Failure to Disinfect (1175); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Date 01/01/1900

Event Type  Injury  

Event Description

It was reported that during an investigation study of journey ii and legion implants conducted by hospital/doctor and not sponsored by (b)(4), 14 of 57 surgeries present a complaint (one surgery per patient).The complications were swelling, pain and infection.13 of the complaints were from journey ii patients and 1 of the complaints was from a (b)(6) patient.The hospital is blaming the sterilization process of cutting blocks.No further information is available at the moment.

Manufacturer Narrative

It was reported that during an investigation study of journey ii and legion implants conducted by hospital/doctor and not sponsored by sn, 14 of 57 surgeries present a complaint.The complications were swelling, pain and infection.The affected complaint device, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.As device information was not made available, device history record, sterilization documentation and complaint history review cannot be completed.There is no information that would suggest the device failed to meet specifications.A relationship, if any, between the device and the reported incident could not be corroborated.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.Based on this investigation, the need for corrective action is not indicated.The sterilization process, however, could not be ruled out as a possible contributing factor.The patient impact beyond the reported events could not be determined.Without the return of the actual product involved and no patient medical records available, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: UNKN JOURNEY INSTRUMENT
• Type of Device: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10160615
• MDR Text Key: 195362668
• Report Number: 1020279-2020-02443
• 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
• Report Date: 11/10/2020

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
• Device Operator: Health Professional
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/18/2020
• Initial Date FDA Received: 06/16/2020
• Supplement Dates Manufacturer Received: 11/03/2020
• Supplement Dates FDA Received: 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention