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

Catalog Number	66800042
Medical Device Problem Code	Mechanics Altered (2984)
Health Effect - Clinical Codes	Laceration(s) (1946); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during debridement, it was noticed that a versajet exact assy, 45 degree x 8mm and a versajet exact assy, 45 degree x 14mm would not turn the key, resulting in having to debride manually.There was a non significant delay and the procedure was finish by changing the surgical technique.Viable tissue was also removed.The patient was not harmed beyond the reported issue.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
The device was not returned for evaluation; therefore, a device analysis could not be performed.A review of the production order did not reveal a manufacturing abnormality that could cause or contributed to the reported incident.A review of complaint history for the part number over the past 14 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the instructions for use documents for versajet ii exact/versajet ii plus hydrosurgery system handpieces revealed in instructions for use section that the orange pump cartridge should be inserted into the handpiece connection port located on the front of the console until fully seated and then turn clockwise to the 3 o¿clock position.When locked correctly, the circular light surrounding the connection port should illuminate green.A review of the risk management file revealed this failure mode/adverse event was previously identified.The anticipated risk level is still adequate.A historical review concluded that no prior escalated actions related to this part number and failure mode.Factors that could contribute to the reported event include degradation problem identified from the console.This is common occurrence, saline deposits build up inside the unique interlock, if not removed it can make the insertion and removal of the key difficult.No manufacturing, packaging, labelling, design, concerns nor adverse trend have been observed; therefore, no corrective actions are deemed necessary.
Additional Manufacturer Narrative
H3, h6: the device was returned for evaluation; a visual inspection was performed.No issues noted.Device was not returned in original packaging.A functional evaluation was performed.The device passed all functional tests and performed as intended.No problems were found.A review of the production order did not reveal a manufacturing abnormality that could cause or contributed to the reported incident.A review of complaint history for the part number over the past 14 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the instructions for use documents for versajet ii exact/versajet ii plus hydrosurgery system handpieces revealed in instructions for use section that the orange pump cartridge should be inserted into the handpiece connection port located on the front of the console until fully seated and then turn clockwise to the 3 o¿clock position.When locked correctly, the circular light surrounding the connection port should illuminate green.A review of the risk management file revealed this failure mode/adverse event was previously identified.The anticipated risk level is still adequate.A historical review concluded that no prior escalated actions related to this part number and failure mode.Since no defects were found on the returned device, no factors that can contribute to the reported event can be delineated.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Corrected data: h6 (health effect - clinical code).

• 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 ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 19817775
• Report Number: 8043484-2024-00071
• Device Sequence Number: 15624213
• Product Code: FQH
• UDI-Device Identifier: 00040565124698
• UDI-Public: 00040565124698
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/04/2026

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: 07/29/2024
• Device Catalogue Number: 66800042
• Device Lot Number: 51052266
• 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: 07/02/2024
• Supplement Date Received by Manufacturer: 09/26/2024; 04/30/2026
• Initial Report FDA Received Date: 07/24/2024
• Supplement Report FDA Received Date: 09/30/2024; 05/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2022
• 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
• Patient Sex: Unknown