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

Model Number	66800041
Medical Device Problem Code	Decrease in Pressure (1490)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during debridement, two (2) versajet exact assy, 45 degree x 14mm failed, in one the water did not come out this event happened during inspection therefore there was no patient involved at that moment and the other device did not have pressure but there was water coming out with the second device there was a delay greater 30 minutes with patient under anesthesia.Procedure was resumed, with a s+n back-up device.Patient was not injured as consequence of this problem.
Additional Manufacturer Narrative
Internal reference number: (b)(4).
Additional Manufacturer Narrative
H3, h6: the device was returned for evaluation, images and videos was also supplied.A review of the images show that there was insufficient flow to the handpiece, and that debridement could not be performed.A visual and functional evaluation was performed.Inspection was performed on the exterior of product and no physical damage was observed.The unit primed.The distal handpiece output sputtered and sprayed for about 10 seconds and then it began to produce a strong steady stream and functioned as designed.A documentation review was performed manufacturing records and processes.The manufacturing records and processes for the reported batch contain no contributory factors, records confirm that this batch was manufactured, meeting the required specifications.All inspection and testing requirement was met prior to release.Complaint history and escalation actions.Historical review details previous cases of this nature, which are considered isolated in scope and there are no open nor closed escalation actions.Related to this event type.A review of the risk management files, find that the reported event and associated harms are anticipated, no updates are required.The probable causer remains unknown, factors may include that air may have entered the saline inflow line no manufacturing, packaging, labelling, design, concerns nor adverse trend have been observed, therefore no corrective actions are deemed necessary.

• Brand Name: VERSAJET EXACT ASSY, 45 DEGREE X 14MM
• Common Device Name: LAVAGE, JET
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 16820798
• Report Number: 8043484-2023-00030
• Device Sequence Number: 6671146
• Product Code: FQH
• UDI-Device Identifier: 00040565124681
• UDI-Public: 00040565124681
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K143115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2024

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?: No
• Device Expiration Date: 07/06/2024
• Device Model Number: 66800041
• Device Catalogue Number: 66800041
• Device Lot Number: 51046070
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2023
• Supplement Date Received by Manufacturer: 04/12/2024
• Initial Report FDA Received Date: 04/26/2023
• Supplement Report FDA Received Date: 04/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown