MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. VERSAJET EXACT ASSY, 15 DEGREE X 14MM; LAVAGE, JET

Model Number	66800040
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during an arthroscopy, the versajet exact assy, 15 degree x 14mm device was found to be leaking.The procedure was cancelled.Patient was not injured as consequence of this problem.
Additional Manufacturer Narrative
The device was returned for evaluation.A visual and functional assessment was performed.No issues were noted, there was no obstruction at the distal output opening.The device primed, leaking was observed from the pump interface chamber of the test console.The probable cause was established to be a result of human factors, a component was found to be missing.A documentation review was performed.Batch record review revealed no contributory factors, records detail the batch met the required specifications prior to release into distribution.The instruction for use, ifu provides adequate support regarding excessive spray and spattering, which may be described as leaks.Complaint history records detail no further events or complaints from this batch.Corrective actions, there are no open nor closed escalation actions within scope and none considered.The risk management documentation anticipates the event, the risk rating in the risk file is not impacted and acceptable.This complaint is deemed isolated in scope, and is anticipated, with no adverse trends observed, no corrective actions are deemed necessary.

• Brand Name: VERSAJET EXACT ASSY, 15 DEGREE X 14MM
• Common Device Name: LAVAGE, JET
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull, east riding; yorkshire, hu3 2bn ; UK
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding; yorkshire, hu3 2bn ; UK
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 15923636
• Report Number: 8043484-2022-00204
• Device Sequence Number: 17445641
• Product Code: FQH
• UDI-Device Identifier: 00040565124674
• UDI-Public: 00040565124674
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K143115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2023

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: 01/04/2024
• Device Model Number: 66800040
• Device Catalogue Number: 66800040
• Device Lot Number: 50992961
• 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: 11/08/2022
• Supplement Date Received by Manufacturer: 04/28/2023
• Initial Report FDA Received Date: 12/06/2022
• Supplement Report FDA Received Date: 05/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2022
• 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: Required Intervention
• Patient Sex: Male