MAUDE Adverse Event Report: DEPUY MITEK LLC US 4590 FMS SOLO IRRIGATION PUMP -NS; DISTENSION UNIT, FLUID, ARTHROSCOPIC

Catalog Number 284590

Device Problem Break (1069)

Patient Problem Not Applicable (3189)

Event Date 10/24/2019

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Udi: (b)(4).Investigation summary: the complaint device was received at the service center and evaluated.The sales rep reported an issue of the device was not maintaining the pressure.Per service manual operational and diagnostic, this complaint cannot be confirmed.However, the door of the device was found to be broken.It was replaced to resolve the issue.After repair, the device was found to be working according to the specifications.As the reported problem was not confirmed, a root cause for the issue that was experienced by the user cannot be determined.Also, with the available information, we cannot determine what cause the door to get broken.A review of lot/batch history for each legacy fms product complaint received by mitek chu is not recommended since legacy manufacturing no longer exists, and it is no longer possible to make process corrections or corrective actions.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.

Event Description

It was reported by the sales rep via phone that during a shoulder scope the 4590 fms solo irrigation pump was not maintaining the pressure.Another device was used to complete the procedure without patient consequences.There was a five minute delay reported.During in-house engineering evaluation, it was determined that the door of the device was found to be broken.There was patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: 4590 FMS SOLO IRRIGATION PUMP -NS
• Type of Device: DISTENSION UNIT, FLUID, ARTHROSCOPIC
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6013142063
• MDR Report Key: 9495463
• MDR Text Key: 205266123
• Report Number: 1221934-2019-60059
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705020614
• UDI-Public: 10886705020614
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K002040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 284590
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/18/2019
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1