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

Model Number	66800041
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal reference number: (b)(4).
Event or Problem Description
It was reported that, during a debridement procedure, the water came out of the key of the versajet exact assy, 45 degree x 14mm once correctly inserted into the console.The surgery was completed, after a significant delay, with a s+n back-up device.No injuries were reported.
Additional Manufacturer Narrative
H3, h6: the device was not available for evaluation; the shipping information was provided, and all efforts were made to locate the device, however, the subject device was not made available to the designated complaint unit and thus a physical product evaluation could not be performed.A device history record review could not be performed, as the part and batch number information provided did not match into the system.The batch number provided is not valid within the system, however the review of complaint history for the part number was performed and it revealed a low number of similar events.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no open nor closed escalation actions within the scope of this investigation.The root cause of the reported event could not be determined since the device was not made available to the designated complaint unit for evaluation.Please refer to the instructions for use for precautions and warnings related to the use of the device.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.

• 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: 17254010
• Report Number: 8043484-2023-00042
• Device Sequence Number: 7912463
• Product Code: FQH
• UDI-Device Identifier: 00040565124681
• UDI-Public: 00040565124681
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K143115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2025

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: 07/06/2024
• Device Model Number: 66800041
• Device Catalogue Number: 66800041
• Device Lot Number: 5143069
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2023
• Supplement Date Received by Manufacturer: 05/08/2025
• Initial Report FDA Received Date: 07/05/2023
• Supplement Report FDA Received Date: 05/12/2025
• 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): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown