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

Model Number	66800042
Medical Device Problem Code	Failure to Prime (1492)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the versajet handpiece would not prime.No patient was involved.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H3, h6: the device intended for use in treatment was returned for evaluation.A relationship between the reported event and device could be established.A visual inspection was performed and showed no blockage was observed at the distal output orifice as observed under a microscope.A functional inspection was performed and showed there was no water flow as the feed line was connected to the water supply.The unit would not prime as the console was ramped up.The feed line was disconnected from the pump cartridge which allowed water to flow directly to the feed line fitting at the pump cartridge.This was a manual prime.The unit then primed and cut.A root cause could not be determined.Probable root cause may be an internal obstruction.The manufacturing records show no evidence that the product did not meet specification at the time of manufacture.A complaint review indicated other failures reported.This investigation is now complete with no further action deemed necessary.Smith and nephew will continue to monitor for adverse trends related to this product.

• 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: 11243789
• Report Number: 8043484-2021-00194
• Device Sequence Number: 17033217
• Product Code: FQH
• UDI-Device Identifier: 00040565124698
• UDI-Public: 00040565124698
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K143115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2021

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: 06/17/2022
• Device Model Number: 66800042
• Device Catalogue Number: 66800042
• Device Lot Number: 50879312
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2021
• Initial Date Received by Manufacturer: 01/07/2021
• Supplement Date Received by Manufacturer: 06/07/2021
• Initial Report FDA Received Date: 01/28/2021
• Supplement Report FDA Received Date: 06/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1