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

Model Number	66800042
Medical Device Problem Codes	Connection Problem (2900); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during a debridement procedure, a versajet ii exact 45 degree 8mm handpiece fell out.In addition, the metal plug failed to connect to the console.Surgery was completed, after a 15 min delay, with a back-up handpiece.During this delay, the patient received additional anesthesia.
Additional Manufacturer Narrative
The device was not returned for evaluation.A documentation review was performed.Historical review has revealed no other cases from the reported product or lot number, there are no open nor closed escalation actions within scope.Manufacturing records and associated processes detail no contributory factors, records reveal the device met the required specifications upon release into distribution.The associated risk files adequately mitigate the event.The instruction for use details the steps taken to fully engage the handpiece into the console.As the report details that the device became detached during debridement, initial connection can be discounted as a contributory factor.The probable cause remains unknown.Without the opportunity to evaluate the console or the handpiece no additional factors can be provided.No manufacturing quality concerns have been observed, therefore no corrective actions are deemed necessary.".

• 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
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 15492334
• Report Number: 8043484-2022-00186
• Device Sequence Number: 1957526
• Product Code: FQH
• UDI-Device Identifier: 00040565124698
• UDI-Public: 00040565124698
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K143115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2023

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?: Yes
• Device Expiration Date: 10/29/2023
• Device Model Number: 66800042
• Device Catalogue Number: 66800042
• Device Lot Number: 50975397
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2022
• Supplement Date Received by Manufacturer: 02/14/2023
• Initial Report FDA Received Date: 09/27/2022
• Supplement Report FDA Received Date: 02/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown