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

Model Number	66800044
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a debridement procedure in the op, the metal part of a versajet plus assy, 45 degree x 14mm broke off at the top.It was unknown how the procedure was finished.The procedure was successfully completed without delay.No other complications were reported.
Event or Problem Description
It was reported that, during a debridement procedure in the op, the metal part of a versajet plus assy, 45 degree x 14mm broke off at the top outside of the patient and no piece fell into the patient.The procedure was successfully completed without delay using a smith and nephew back up device.No other complications were reported.
Additional Manufacturer Narrative
H10: the device, used in treatment, has been returned and evaluated.Visual inspection reported.The high pressure and evacuation hoses were severed approximately 2.0 inches from the edge of the distal hand piece hose entrance.The rest of the hoses and the pump cartridge were not included.A specimen vial with a small piece of metal was included.Functional examination of the device as received found no damage or broken pieces.Comparison to the weldment drawings confirmed the device was intact per specification and the metal piece included in the specimen vial is not a part of the final assembly of the weldment.We have not been able to establish a relationship between the device and the reported event or determine a root cause.The piece of rogue metal may have been inadvertently lodged in the evacuation channel but this cannot be determined.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 no 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.

• 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: 11816105
• Report Number: 8043484-2021-01099
• Device Sequence Number: 11569159
• Product Code: FQH
• UDI-Device Identifier: 00040565124773
• UDI-Public: 00040565124773
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K110958
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2021

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 Expiration Date: 08/14/2022
• Device Model Number: 66800044
• Device Catalogue Number: 66800044
• Device Lot Number: 50890173
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2021
• Initial Date Received by Manufacturer: 04/22/2021
• Supplement Date Received by Manufacturer: 10/20/2021
• Initial Report FDA Received Date: 05/13/2021
• Supplement Report FDA Received Date: 10/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1