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

Catalog Number	66800044
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that, during a debridement, the pump cartridge (metal tip with orange handle) of a versajet plus assy, 45 degree x 14mm, shoot out of the console port, due to lack of tightness of the seal.This occurred on a new replaced console.The procedure was resumed, after a significant delay, by changing to surgical techniques.No injury was reported as a consequence of this issue.
Additional Manufacturer Narrative
Additional information: h6 (component code, type of investigation, investigation findings, investigation conclusions).Results of investigation: the device was not returned for evaluation; therefore, a device analysis could not be performed.A review of the associated batch record showed that this batch passed all acceptance criteria and was compliant upon release for distribution.There were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A review of complaint history revealed 2 similar events for the listed product for the timeframe.A review concluded that there are no prior escalated actions related to this part number and failure mode.A review of the risk management file revealed this failure mode/adverse event was previously identified.The anticipated risk level is still adequate.A factor that could contribute to the reported event include that the handpiece was not full rotated 90 degrees as specified in the instructions for use, or a component failure at the connection port of the console.No manufacturing, packaging, labelling, design, concerns nor adverse trend have been observed; therefore, no corrective actions are deemed necessary.

• Brand Name: VERSAJET PLUS 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: 19596283
• Report Number: 8043484-2024-00064
• Device Sequence Number: 8493248
• Product Code: FQH
• UDI-Device Identifier: 00040565124773
• UDI-Public: 00040565124773
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K143115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/10/2025
• Device Catalogue Number: 66800044
• Device Lot Number: 51121780
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2024
• Supplement Date Received by Manufacturer: 09/26/2024
• Initial Report FDA Received Date: 06/24/2024
• Supplement Report FDA Received Date: 10/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2023
• 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
• Patient Sex: Unknown