MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. SIMPULSE PLUS SUCTION IRRIGATOR TIP; LAVAGE, JET

Catalog Number	0057621
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject product was returned for evaluation.Visual evaluation of the sample confirms the showerhead tip detached during use.There is no apparent physical damage and no signs of excessive force that were applied to the tip while in use.During the manufacturing process, the shaft end of the connector is bonded to the irrigation tip with an adhesive.The sample evaluation finds little to no cyclohexanone present.Root cause is found to be manufacturing related.A review of the manufacturing records was performed and found that the lot was manufactured to specification.This is the first reported complaint for the subject lot of (b)(4) units manufactured in march of 2019.
Event or Problem Description
It was reported that during a total hip procedure, the tip of the simpulse plus showerhead tip fell off during surgery.It is unknown if excessive pressure was being applied at the time of the reported detachment.All detached pieces of the device were retrieved.Another device was used to complete the case without further issue.There was no patient injury reported.

• Brand Name: SIMPULSE PLUS SUCTION IRRIGATOR TIP
• Common Device Name: LAVAGE, JET
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 9204408
• Report Number: 1213643-2019-10055
• Device Sequence Number: 447574
• Product Code: FQH
• UDI-Device Identifier: 00801741010415
• UDI-Public: (01)00801741010415
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K830386
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/17/2019

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: 02/28/2024
• Device Catalogue Number: 0057621
• Device Lot Number: JUDQF142
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2019
• Initial Report FDA Received Date: 10/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1