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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the versajet ii handpiece did not work during a surgery.Water did not start to run after it had been connected.There was no harm done to the patient and the operation was only delayed a short time, while getting a new handpiece.
Additional Manufacturer Narrative
H3, h6: the device, that was used in treatment, was returned for evaluation.There was a relationship between the reported event and the device.A visual inspection was performed and showed no blockage was observed at the distal output orifice.The piston assembly was in the middle position within the chamfer.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 pump cartridge was disassembled.The pump cartridge had been assembled correctly at manufacture.The piston assembly was removed from the chamfer.One of the four grasping tabs was severed.The missing tab would not allow the device to prime properly.The root cause has been determined to be a component failure.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 east riding of yorkshire HU3 2 BN; UK HU3 2BN
• MDR Report Key: 10764339
• Report Number: 8043484-2020-03372
• Device Sequence Number: 19666703
• Product Code: FQH
• UDI-Device Identifier: 00040565124773
• UDI-Public: 00040565124773
• Combination Product (Y/N): N
• Initial Reporter Country: IC
• PMA/510(K) Number: K143115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2021

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: 50757925
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2021
• Initial Date Received by Manufacturer: 10/02/2020
• Supplement Date Received by Manufacturer: 04/08/2021
• Initial Report FDA Received Date: 10/30/2020
• Supplement Report FDA Received Date: 04/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1