MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKNOWN 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 Problems Unspecified Infection (1930); Pain (1994)

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 s&n, 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 legion 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.

Manufacturer Narrative

The device, used in treatment, was returned for evaluation.The clinical/medical team concluded, per complaint details, 14 patients (13 jii and 1 lgn) experienced complications such as swelling, pain and infection post primary implantation and ¿the hospital is blaming the sterilization process of cutting blocks¿.No patient specific details or further information has been provided for inclusion in a medical investigation.It is unknown if the s+n ifu (b)(6) is being followed.The ¿instructions for care, maintenance, cleaning and sterilization (81103630_a) indicates ¿the user¿ must ¿validate their sterilization equipment to ensure that the recommended parameters are achieved¿.Based on the limited information provided, the root cause of the reported (common) post-operative symptoms could not be definitively concluded.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.No further medical assessment could be rendered at this time.Should clinically relevant documentation become available, the medical investigation task may be re-evaluated.A visual inspection confirmed the journey dcf ap fem cut blk 3 shows nicks and scratches.The device shows significant signs of wear/usage.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 have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A review of complaint history for the listed part revealed no prior complaints for the listed batch.A review of the risk management file revealed this failure mode was previously identified.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.This is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.For cleaning procedures please refer to smith and nephew¿s recommended cleaning methods given in our cleaning and sterilization brochure-¿instructions for care, maintenance, cleaning and sterilization of smith and nephew orthopedic devices¿, 71381339.The document is available from customer service or via the smith and nephew website, which suggests using a surgical scrub brush to remove visible debris.Product was sterilized according to sterilization release documentation from quality control.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 warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: UNKNOWN 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: 10158837
• MDR Text Key: 195279008
• Report Number: 1020279-2020-02421
• 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
• Report Date: 04/29/2021

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?: No
• Device Operator: Health Professional
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2021
• Initial Date Manufacturer Received: 05/18/2020
• Initial Date FDA Received: 06/16/2020
• Supplement Dates Manufacturer Received: 11/03/2020; 04/12/2021
• Supplement Dates FDA Received: 11/16/2020; 04/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention