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

Model Number	66800045
Medical Device Problem Codes	Material Separation (1562); Explosion (4006)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: case (b)(4).
Event or Problem Description
It was reported that, during a lavage procedure, while using a versajet plus assy, 45 degree x 8mm, a problem occurred with the cable that connects the piece to the console itself.The device began to be used normally, but after five (5) minutes of use the cable that connects the handpiece to the console exploded.The console was not damaged and continues to work perfectly.It was impossible to continue using the device, so the surgery had to be suspended.No injuries were reported.
Additional Manufacturer Narrative
H3, h6: the device was not returned preventing an evaluation taking place.Documentation review.The images supplied, confirm that the high pressure line had detached the associated batch records review has confirmed that the batch passed all acceptance criteria and was compliant upon release for distribution.There were no indications to suggest the device did not meet product specifications nor did it allege any product deficiencies upon release into distribution.Complaint history has revealed a small number of cases of this nature, which are isolated in scope, and there are no open or closed escalation actions.The "ifu" instruction for use details adequate details regarding the safe operation and use, including detail that the yellow high-pressure tube on handpiece is not kinked, obstructed or tangled.The risk management documentation for versajet has been reviewed and anticipates this failure against the description ¿hose ruptures - loss of therapy; saline splash, jet emitted¿.No injuries or harms were reported because of this issue.The probable cause remains unknown, factors may include that the high- pressure hose became kinked or obstructed.No manufacturing, packaging, labelling, design, concerns nor adverse trend have been observed, therefore no corrective actions are deemed necessary.H6 (health effect - clinical code and medical device problem code).

• Brand Name: VERSAJET PLUS 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 ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 16668647
• Report Number: 8043484-2023-00023
• Device Sequence Number: 15107189
• Product Code: FQH
• UDI-Device Identifier: 00040565124780
• UDI-Public: 00040565124780
• Combination Product (Y/N): N
• Initial Reporter Country: CS
• PMA/510(K) Number: K143115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: 66800045
• Device Catalogue Number: 66800045
• Device Lot Number: 50963207
• 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: 03/09/2023
• Supplement Date Received by Manufacturer: 02/21/2024
• Initial Report FDA Received Date: 04/03/2023
• Supplement Report FDA Received Date: 02/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/31/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown