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

Catalog Number 66800042

Device Problems Material Rupture (1546); Sparking (2595)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/03/2023

Event Type  malfunction  

Manufacturer Narrative

H10: internal complaint reference: (b)(4).

Event Description

It was reported that, during a debridement procedure, the cable of a versajet exact assy, 45 degree x 8mm exploded and smoke and sparks were seen on the severed cable/wire.The podiatrist immediately stopped using it.There was no notable patient or user harm.It is unknown how procedure was completed or if a delay occurred due to this event.No other complications were reported.

Event Description

It was reported that, during a debridement procedure, the cable of a versajet exact assy, 45 degree x 8mm exploded and smoke and sparks were seen on the severed cable/wire.The podiatrist immediately stopped using it.There was no notable patient or user harm.The procedure was resumed, without any delay, by changing the surgical technique to sharp surgical dissection.

Manufacturer Narrative

H10: additional information updated section b5 and h6 (impact code).

Manufacturer Narrative

H3, h6: the device was returned for a physical evaluation.Visual inspection of the returned product found a rupture in the high pressure line near the entrance of the handpiece.It was also noted a substance build up was near the distal tip.Functional system testing could not be performed due to the condition of the device.The high-pressure line was cut near the base of the handpiece to check for blockages - water was flowed from the proximal and distal ends of the high-pressure line and no blockage was found; water flowed freely from the rupture point in the hose.A review of the manufacturing records showed that this unit passed all acceptance criteria and was compliant upon release for distribution.There were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A review of previous complaints finds that this is one of a small number of complaints reporting forceful separation of the high pressure line.This is the only complaint against items from the reported lot number.There are no open or closed corrective actions previously implemented in relation to this product and failure mode combination.A review of the product risk files, find the combination or product, event type and associated harms are anticipated, with no updates required.Root cause of the ruptured high pressure hose determined to be that there was a blockage within the intended flow path of fluid.The cause of the blockage cannot be determined at this time.Root cause of the reported 'smoke and sparks' remains undetermined.There are no electrical components along the high pressure line to contribute to sparking, potential factors may include that the vaporisation of the fluid in the tube at the time of the rupture may have been perceived as smoke.No manufacturing quality concerns have been observed, therefore no corrective actions are deemed necessary, smith and nephew will continue to monitor for adverse trends relating to the reported allegation.

• Brand Name: VERSAJET EXACT ASSY, 45 DEGREE X 8MM
• Type of Device: 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: 18267499
• MDR Text Key: 329789973
• Report Number: 8043484-2023-00089
• Device Sequence Number: 1
• Product Code: FQH
• UDI-Device Identifier: 00040565124698
• UDI-Public: 00040565124698
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143115
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 66800042
• Device Lot Number: 51046067
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1