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	Burn(s) (1757)
Date of Event	06/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal reference number: (b)(4).
Event or Problem Description
It was reported that during a debridement, it was found that versajet ii exact 45dx14mm, there was no water came out.The hcp re-check if they set up everything correctly but still no water came out.So they change to the second versajet ii exact 45dx14mm same batch number found that the water came out but not able to cut the debride burn.The procedure was performed, after significant delay, with a s+n back-up handpiece.Patient was not injured as consequence of this problem.
Additional Manufacturer Narrative
H3, h6: the associated device was returned and evaluated.The visual inspection revealed the device, the piston assembly was in a middle position within the chamfer.It was also noted using a microscope rust was found near the distal tip.Functional evaluation was performed and revealed that due to piston assembly being stuck in the middle of the chamfer, hand piece had no flow.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history based on the historical data revealed similar events for the listed batch, this failure mode will be monitored for future complaints for any necessary corrective actions.A historical review concluded that there are no prior actions related to this product and event.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate, so no update is required.A factor that could contribute to the reported event include a failure of the piston assembly.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: 17263579
• Report Number: 8043484-2023-00043
• Device Sequence Number: 5884900
• 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): 08/28/2024

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 Model Number: 66800041
• 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: 06/21/2023
• Supplement Date Received by Manufacturer: 08/27/2024
• Initial Report FDA Received Date: 07/05/2023
• Supplement Report FDA Received Date: 08/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown