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

Model Number	66800042
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a versajet exact assy, 45 degree x 8mm exploded when the surgeon activated the foot pedal.Failure happened during a skin graft procedure.No harm reported to patient.
Additional Manufacturer Narrative
The device, used in treatment, has been returned and evaluated, visual inspection reported no faults found, the functional evaluation found the device had a stress fracture in the hose, establishing a relationship between the device and the reported events.The root cause identified as contact with another force, a review of the manufacturing records found that there was no evidence that the product didn't meet specifications at the time of manufacture, a complaint history review found further instances of the reported event.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 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
• MDR Report Key: 12041888
• Report Number: 8043484-2021-01540
• Device Sequence Number: 4218679
• Product Code: FQH
• UDI-Device Identifier: 00040565124698
• UDI-Public: 00040565124698
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K143115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2021

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 Expiration Date: 11/11/2022
• Device Model Number: 66800042
• Device Catalogue Number: 66800042
• Device Lot Number: 50906003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2021
• Initial Date Received by Manufacturer: 06/08/2021
• Supplement Date Received by Manufacturer: 08/09/2021
• Initial Report FDA Received Date: 06/22/2021
• Supplement Report FDA Received Date: 08/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1