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

Model Number	284590
Medical Device Problem Codes	Break (1069); Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Udi: (b)(4).Investigation summary: the device was received at the service center and evaluated.There was no allegation of malfunction against the device from the customer, however, defects were found with the device during service evaluation.This complaint can be confirmed.During the service evaluation the following defects were identified: minor scratches on the unit.Broken door.The repair of the device was however declined, and it is being placed into long term hold.The shipment/storage damage was identified as the root cause for the device failure during the service evaluation.At this point in time, no corrective action is required, and no further action is warranted.Depuy 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.Device history lot: manufacturing record evaluation is not required as the reported event is not associated with the manufacturing process and/or the potential cause of the defect cannot be associated to manufacturing.
Event or Problem Description
It was reported through in-house inspection of returned capital equipment that the door on the 4590 fms solo irrigation pump was cracked.During in-house engineering evaluation, it was determined that the device had a broken door.There was no procedure nor patient involvement reported.No additional information was provided.

• Brand Name: 4590 FMS SOLO IRRIGATION PUMP -NS
• Common Device Name: DISTENSION UNIT, FLUID, ARTHROSCOPIC
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 13359715
• Report Number: 1221934-2022-00302
• Device Sequence Number: 13868642
• Product Code: HRX
• UDI-Device Identifier: 10886705020614
• UDI-Public: 10886705020614
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K002040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial

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 Model Number: 284590
• Device Catalogue Number: 284590
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2022
• Initial Report FDA Received Date: 01/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown