MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. VERSAJET EXACT ASSY, 15 DEGREE X 14MM; LAVAGE, JET

Model Number	66800040
Medical Device Problem Codes	Leak/Splash (1354); Improper Flow or Infusion (2954); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during debridement surgery, the bending part of a versajet handpiece did not match, for which water splashed in all directions.Surgery was resumed, after a significant delay greater than 30 min, with a smith & nephew back-up device.Patient was not injured as consequence of this problem.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).H3, h6: the affected product has been received and evaluated.A visual and functional evaluation has been performed, confirming that the distal tip was bent, which caused the handpiece to not perform correctly, resulting in an inaccurate stream.The probable cause is confirmed to be a raw material defect.Documentation review.The manufacturing records, reveal no contributory factors, the batch associated to this product was released according to the finished product specifications.Risk documentation has been reviewed, this material defect and functional failure is anticipated and deemed to be acceptable.Historical review, considering the affected product and event type, has revealed no other cases from this batch, with no relevant historical corrective actions.No adverse trends have been observed therefore no further action is deemed necessary at this time.

• Brand Name: VERSAJET EXACT ASSY, 15 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
• 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 ; 101 hessle road; hull east riding of yorkshire HU3 2-BN ; UK HU3 2BN ; 5123913905
• MDR Report Key: 14290067
• Report Number: 8043484-2022-00142
• Device Sequence Number: 12114767
• Product Code: FQH
• UDI-Device Identifier: 00040565124674
• UDI-Public: 00040565124674
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K143115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2024

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: 08/31/2023
• Device Model Number: 66800040
• Device Catalogue Number: 66800040
• Device Lot Number: 50963215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2022
• Supplement Date Received by Manufacturer: 02/29/2024
• Initial Report FDA Received Date: 05/05/2022
• Supplement Report FDA Received Date: 03/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown