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

Model Number	66800044
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the debridation of the wound started without issue but after one minute of functioning, the device made a little explosion and water started to come out through the hose that is introduced to the device.Then, the device gave a error warning signal and it did not work again.It did not get pressure and continuously released water through the hose.The procedure was completed with a smith and nephew back up device.No harm or injury reported.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was not returned for evaluation.The information provided was reviewed, we have not been able to establish a relationship between the device and the reported event or determine a root cause on this occasion.Probable causes may be an obstruction, component failure, or connection issue.A review of the associated batch manufacturing records confirmed that the device met manufacturing specifications at the point of release.The complaint history review found further instances of the reported event.This investigation is now complete with no further action deemed necessary.We will continue to monitor for any adverse trends relating to this product range.Smith + nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.

• 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 HU3 2 BN; UK HU3 2BN
• MDR Report Key: 11263010
• Report Number: 8043484-2021-00230
• Device Sequence Number: 14278497
• Product Code: FQH
• UDI-Device Identifier: 00040565124773
• UDI-Public: 00040565124773
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K110958
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2021

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 Model Number: 66800044
• Device Catalogue Number: 66800044
• Device Lot Number: 50860912
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/11/2021
• Supplement Date Received by Manufacturer: 04/21/2021
• Initial Report FDA Received Date: 02/01/2021
• Supplement Report FDA Received Date: 04/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1