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

Model Number	66800042
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a wound debridement surgery, no water flow was noticed through the tip of a versajet exact assy, 45 degree x 8mm handpiece; instead, it was noticed to flow through the waste liquid tube.No delay in surgery was reported as a smith and nephew backup handpiece was available.Neither patient injury nor other complications were reported.
Additional Manufacturer Narrative
The device used in treatment was not returned for evaluation, all provided information has been reviewed and we have not been able to establish a relationship between the device and the reported event or determine a root cause, probable root cause may include, an obstruction of flow, 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.
Additional Manufacturer Narrative
Information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The information states that it was determined that this event did not lead to death or serious deterioration in the state of health of a patient, user or other person.When the malfunction was noticed, a backup device was used to continue surgery, no serious injury was reported.Therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

• 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: 11933517
• Report Number: 8043484-2021-01346
• Device Sequence Number: 19919622
• Product Code: FQH
• UDI-Device Identifier: 00040565124698
• UDI-Public: 00040565124698
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 03/23/2022

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: 05/18/2022
• Device Model Number: 66800042
• Device Catalogue Number: 66800042
• Device Lot Number: 50873760
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 05/24/2021
• Supplement Date Received by Manufacturer: 09/15/2021; 03/23/2022
• Initial Report FDA Received Date: 06/03/2021
• Supplement Report FDA Received Date: 09/15/2021; 03/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown