MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. VERSAJET EXACT ASSY, 45 DEGREE X 14MM; LAVAGE, JET

Catalog Number 66800041

Device Problem Connection Problem (2900)

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

Event Date 10/18/2019

Event Type  malfunction  

Event Description

It was reported that during debridement utilizing a versajet with the setting of 10, the high pressure tube came off from the orange cartridge.No patient harm.No delay.The surgery was completed with back-up handpiece.The device will be returned for investigation.

Manufacturer Narrative

The device intended for use in treatment was returned for evaluation a establishing a relationship between the event reported.A visual inspection the high-pressure tubing was still properly connected to the orange pump cartridge, however the tubing had disconnected from the jet tube filter assembly of the hand piece.The functional evaluation found the output orifice of the jet tube assembly was blocked by debris.This caused a buildup of pressure which caused the high-pressure tubing to separate from the jet tube filter assembly.The versajet system is a high-pressure device, which uses saline in its operation.A buildup of oxidized saline on the interlock can corrode if not removed, this issue can contribute to the reported event.The instructions for use, details guidance on the maintenance and cleaning of the device.It is highly recommended that these instructions are followed to prevent re-occurrences of this type of event.A review of manufacturing records for the reported lot/batch, found no non-conformances or anomalies during production.The device/product met all specifications upon release into distribution.Complaint history for the reported event has been reviewed, revealing only this instance, with no further action deemed necessary.This investigation is now complete, but please be assured that all products are released to market following rigorous quality checks during production and prior to despatch.By acknowledging and investigating your complaint this collaboration enables us to drive our passion to continuously review, improve and steer our shared purpose of providing the best possible outcome for customer and patients.Smith and nephew take all customer complaints and concerns seriously, we strive to have the best understanding of our patients needs and have built a strong culture of care, collaboration and courage to offer a service which we are proud of.

• Brand Name: VERSAJET EXACT ASSY, 45 DEGREE X 14MM
• Type of Device: LAVAGE, JET
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull ; UK
• MDR Report Key: 9344194
• MDR Text Key: 167160793
• Report Number: 8043484-2019-00846
• Device Sequence Number: 1
• Product Code: FQH
• Combination Product (y/n): N
• PMA/PMN Number: K110958
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 07/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 66800041
• Device Lot Number: 50764650
• Initial Date Manufacturer Received: 10/25/2019
• Initial Date FDA Received: 11/19/2019
• Supplement Dates Manufacturer Received: 07/28/2020
• Supplement Dates FDA Received: 07/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1