MAUDE Adverse Event Report: DEPUY MITEK LLC US 4580 FMS DUO+ PUMP/SHAVER COMBO -NS; DISTENSION UNIT, FLUID, ARTHROSCOPIC

Model Number 284580

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (b)(4).Udi: (b)(4).

Event Description

It was reported by affiliate via mail the 4580 fms duo+ pump/shaver combo ns.After surgery, the plastic cover is broken.The device is available for evaluation.

Manufacturer Narrative

This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: investigation summary: the device was received and evaluated at the service center.The reported complaint that the plastic cover of the device is broken, was confirmed.It was found that the right cover was damaged.Further, the pump roller was defective and the device was not calibrated correctly.The pressure mechanism was re-adjusted, a mechanical upgrade was performed, defective material exchanged, missing material renewed, defective pump roller replaced along with the irreparable cover, and the device was cleaned, newly calibrated, repaired, tested and found to be fully functional.The physical damage to the device can be attributed to user mishandling, probably due to a fall during transport or storage.This would have further damaged the pump roller.This serialized device (serial : (b)(6) was manufactured prior to the current manufacturer, therefore a dhr review cannot be performed since the original manufacturer no longer exists and therefore the manufacturer can no longer make any process correction or corrective actions if needed.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.

• Brand Name: 4580 FMS DUO+ PUMP/SHAVER COMBO -NS
• Type of Device: DISTENSION UNIT, FLUID, ARTHROSCOPIC
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10590658
• MDR Text Key: 208715018
• Report Number: 1221934-2020-02756
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705020607
• UDI-Public: 10886705020607
• Combination Product (y/n): N
• PMA/PMN Number: K954465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 284580
• Device Catalogue Number: 284580
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2020
• Date Manufacturer Received: 09/29/2020
• Patient Sequence Number: 1