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

Model Number	66800044
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that under surgery, the versajet handset stopped working after 10 min.Handle stopped providing any water at all.The pumping sound changed to a higher frequency and rate.No error messages.Suction remained functioning.There was a short delay.The treatment was completed by manual debridement and due this inferior there was soft tissues removal, and increased resection of vital tissue.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, has been returned for evaluation.A visual inspection reported no defects.The functional evaluation found the device primed and cut as designed, there was no problem found.We have not been able to establish a relationship between the reported event and the device.Our clinical investigation concluded: although requested, the operative reports were not provided for review.Based on the limited information provided the clinical root cause of the reported events could not be definitively concluded.The device was returned for evaluation and based on the functional evaluation results ¿no problem was found.¿ a user vs procedural event cannot be ruled out as a contributing factor and the probable cause.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 in the past years.The ifu has been reviewed and contains comprehensive instructions on the safe operation and use of the device.The associated risk files contain details relating to harm.This investigation is now complete with no further action deemed necessary.Smith + nephew will continue to monitor for any adverse trends relating to this product range.

• 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: 10754331
• Report Number: 8043484-2020-03317
• Device Sequence Number: 1061380
• Product Code: FQH
• UDI-Device Identifier: 00040565124773
• UDI-Public: 00040565124773
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 66800044
• Device Catalogue Number: 66800044
• Device Lot Number: 50840794
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2021
• Initial Date Received by Manufacturer: 09/30/2020
• Supplement Date Received by Manufacturer: 02/26/2021
• Initial Report FDA Received Date: 10/29/2020
• Supplement Report FDA Received Date: 02/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention