MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. VERSAJET PLUS ASSY, 45 DEGREE X 14MM; LAVAGE, JET

Model Number	66800044
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during surgery performed on (b)(6) 2021, the versajet plus assy, 45 degree x 14mm malfunctioned, the device did not performed tissue excision despite of the level of speed adjusted and all the troubleshooting was done.The procedure proceed with minimal surgical debridement and later then, autolytic debridement.The patient was not harmed.The procedure was completed without significant delays.
Additional Manufacturer Narrative
H3, h6: the device was used in treatment was not returned for evaluation, with all information provided 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 or component failure.No lot/serial number has been provided; therefore, a review of the device history is not possible.A complaint history review found further instances of the reported event.The associated risk files contain details relating to harm.However, as no harm has been alleged then additional review is not required.Instructions for use contains recommendations and precautionary statements for proper use of product.This investigation is now complete with no further action deemed necessary.Smith and nephew will continue to monitor for any adverse trends relating to this product range.
Additional Manufacturer Narrative
H10: after further assessment of the information gathered by the manufacturer, it was identified that this event should be re-evaluated for mdr reporting.The original information stated that the versajet plus assy, 45 degree x 14mm malfunctioned, the device did not performed tissue excision despite of the level of speed adjusted and all the troubleshooting was done.The procedure proceed with minimal surgical debridement and later then, autolytic debridement.The patient was not harmed.The procedure was completed withouth significant delays.However, after further clarification and information received, it was determined that the issue does not meet the criteria to be reportable; and therefore, there was no serious injury.Moreover, if the device malfunction were to recur, it would not be likely to cause or contribute to a death or serious injury.

• 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
• 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: 12013101
• Report Number: 8043484-2021-01496
• Device Sequence Number: 4636557
• Product Code: FQH
• UDI-Device Identifier: 00040565124773
• UDI-Public: 00040565124773
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K143115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/11/2022

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
• Operator of Device: Health Professional
• Device Model Number: 66800044
• Device Catalogue Number: 66800044
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 05/31/2021
• Supplement Date Received by Manufacturer: 09/20/2021; 10/26/2022
• Initial Report FDA Received Date: 06/16/2021
• Supplement Report FDA Received Date: 09/21/2021; 11/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown