MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 SIMPULSE SOLO SUCTION IRRIGATOR; LAVAGE, JET

Catalog Number	0067730
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, the purple small tip of the simpulse solo irrigator became detached.The subject device is not returned for evaluation.Based on the information available and without having the sample to evaluate, no conclusions can be made.Review of manufacturing records confirms product was manufactured to specification, with no indication of a manufacturing related cause for the event reported.To date, this is the only reported complaint for this manufacturing lot of 360 units released for distribution in oct 2022.Device evaluated by mfr: not returned.
Event or Problem Description
As reported, during a left knee stage revision joint replacement procedure, the simpulse solo irrigator was used and the surgeon noticed that the purple small tip (showerhead faceplate) was no longer attached prior to closure.The missing piece was attempted to be located in the surgical site; however, was unable to be found.There was no reported patient injury.

• Brand Name: SIMPULSE SOLO SUCTION IRRIGATOR
• Common Device Name: LAVAGE, JET
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): DAVOL SURGICAL INNOVATIONS -9616067; ave. roberto fierro #6408; parque industrial aeropuerto; cd. juarez, chih s.a. de c.v. 32690 ; MX 32690
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 8005566756
• MDR Report Key: 16380399
• Report Number: 1213643-2023-00047
• Device Sequence Number: 5759621
• Product Code: FQH
• UDI-Device Identifier: 00801741010323
• UDI-Public: (01)00801741010323
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K942886
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/27/2023

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 Catalogue Number: 0067730
• Device Lot Number: JUGW0922
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/23/2023
• Initial Report FDA Received Date: 02/15/2023
• 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: Other
• Patient Sex: Unknown