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

Catalog Number	66800041
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a debridement surgery, after using a versajet exact assy, 45 degree x 14mm for five minutes, a lot of water came out of the handpiece and then it was not possible to continue using it.The procedure was resumed, after a significant delay, with a s+n backup device.No patient injury was reported due to this issue.
Additional Manufacturer Narrative
Internal reference number: (b)(4).
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation, therefore an assessment could not be performed.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 product risk files, find the combination or product, event type and associated harms are anticipated, with no updates required.The probable cause remains unknown, factors may include an internal component failure.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: 17446800
• Report Number: 8043484-2023-00051
• Device Sequence Number: 7491822
• 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): 04/23/2024

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?: Yes
• Device Expiration Date: 09/08/2024
• Device Catalogue Number: 66800041
• Device Lot Number: 51064612
• 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: Not provided
• Supplement Date Received by Manufacturer: 04/19/2024
• Initial Report FDA Received Date: 08/02/2023
• Supplement Report FDA Received Date: 04/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/08/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown