MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY FLEX EXT BLOCK STD; TROUSERS, ANTI-SHOCK

Model Number 74018603

Device Problem Crack (1135)

Patient Problem No Patient Involvement (2645)

Event Date 09/02/2020

Event Type  malfunction  

Event Description

It was reported that during set up inspection process was noticed that the inner snap rings of the journey flex ext block standard are bad and show some cracks.There was no case involved.

Manufacturer Narrative

The device, intended for use in treatment was returned for evaluation.Visual inspection of the returned device confirms that the device has cracks and has signs of wear and tear from use.The device was manufactured in 2014.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.The device is a reusable device that can be exposed to numerous surgeries and cleaning cycles.Probable causes that could contribute to the reported event, as reusable instruments are susceptible to damage from prolonged use and through misuse or rough handling.To avoid compromised performance or damage, it is recommended the device be inspected prior to and after each use and cleaning.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further actions are being taken at this time.

Manufacturer Narrative

H10: smith & nephew is submitting this report pursuant to the provisions of 21 c.F.R.Part 803.This report may be based upon information which smith & nephew has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, or its employees, that the report constitutes an admission that the device, smith & nephew or its employees caused or contributed to the potential event described in this report.

Event Description

It was reported that during set up inspection process was noticed that the inner snap rings of the journey flex ext block standard are bad and show some cracks.There was no case involved.

• Brand Name: JOURNEY FLEX EXT BLOCK STD
• Type of Device: TROUSERS, ANTI-SHOCK
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10617185
• MDR Text Key: 209759544
• Report Number: 1020279-2020-05046
• Device Sequence Number: 1
• Product Code: LHX
• UDI-Device Identifier: 03596010557087
• UDI-Public: 03596010557087
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 11/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 74018603
• Device Catalogue Number: 74018603
• Device Lot Number: 14FM06308
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1