MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. VERSAJET EXACT ASSY, 45 DEGREE X 8MM; LAVAGE, JET

Model Number	66800042
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during debridement, both versajet exact assy, 45 degree x 8mm and versajet plus assy, 45 degree x 14mm were not draining at all and instead spraying back all over the debrided wound bed.Procedure was resumed, with a greater than 30 minutes delay, with a changed in surgical technique.Current health status of the patient is unknown at the present, however, was not harmed.No further complications reported.
Additional Manufacturer Narrative
H10: the device was not returned for evaluation, the reported event cannot be confirmed.A documentation review has confirmed that this device was manufactured and released according to the final product specification, with no contributory factors regarding the reported event.Historical records reviewed, contain reports of a similar nature, with no manufacturing or quality concerns observed, there are no open corrective actions.The risk files mitigate the reported event, which is further delineated within the instruction for use, which provides the probable root cause.Fluid spraying/sputtering can be caused by a build-up of debris in the evacuation orifice.This must be frequently checked during use and cleared away to maintain a steady flow of saline through the handpiece.No manufacturing quality concerns have been observed, therefore no corrective actions are deemed necessary, smith and nephew will continue to monitor for adverse trends.Internal complaint reference number: (b)(4).

• Brand Name: VERSAJET EXACT ASSY, 45 DEGREE X 8MM
• 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 ; 101 hessle road; hull east riding of yorkshire HU3 2-BN ; UK HU3 2BN ; 5123913905
• MDR Report Key: 14290879
• Report Number: 8043484-2022-00146
• Device Sequence Number: 1520213
• Product Code: FQH
• UDI-Device Identifier: 00040565124698
• UDI-Public: 00040565124698
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K143115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/24/2023
• Device Model Number: 66800042
• Device Catalogue Number: 66800042
• Device Lot Number: 50968715
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2022
• Supplement Date Received by Manufacturer: 07/20/2022
• Initial Report FDA Received Date: 05/05/2022
• Supplement Report FDA Received Date: 07/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/24/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown