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

Model Number 66800041

Device Problem Material Rupture (1546)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/22/2021

Event Type  malfunction  

Event Description

It was reported that during set up the versajet hand piece was found faulty.Irrigation connection had a perforation, occurring in spillage as it was connected to irrigation.There was a delay of 5 minutes and a backup was available to start with the treatment.No patient harm reported.

Manufacturer Narrative

The device, was not used in a procedure was not returned for evaluation with all additional information provided we have not been able to establish a relationship between the reported event or determine a root cause.The manufacturing records show no evidence that the product did not meet the specification at the time of manufacture.A complaint history review found other related failures.Probable cause may be a component failure or connection issue.This investigation is now complete with no further action deemed necessary at this stage.Smith + nephew will continue to monitor for any adverse trends relating to this product range.

• 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 east riding of yorkshire HU3 2 BN; UK HU3 2BN
• MDR Report Key: 11326044
• MDR Text Key: 231937672
• Report Number: 8043484-2021-00299
• Device Sequence Number: 1
• Product Code: FQH
• UDI-Device Identifier: 00040565124681
• UDI-Public: 00040565124681
• Combination Product (y/n): N
• PMA/PMN Number: K110958
• 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: 03/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 66800041
• Device Catalogue Number: 66800041
• Device Lot Number: 50782235
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1