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

Catalog Number 284580

Device Problems Crack (1135); Increase in Pressure (1491)

Patient Problem No Patient Involvement (2645)

Event Date 01/01/2019

Event Type  malfunction  

Manufacturer Narrative

Reporter is company employee.Investigation summary:the device was received and evaluated at the service center.There was no allegation of malfunction against the device from the customer, however, defects were found with the device during service evaluation.It was found that the right cover of the device was cracked.Also the right roller pump head was damaged and the over pressure was out of tolerance.The device was found to not be calibrated correctly.A mechanical upgrade was performed, pressure mechanism re-adjusted, and the irreparable cover, the defective pump roller, and the color coding for tube set were replaced.The device was cleaned, newly calibrated, repaired and found to be fully functional.The incorrect calibration of the device may have caused the over-pressure to go out of tolerance.Also the cracked cover is most likely a result of user mishandling of the device.However, given the information provided we cannot discern a definitive root cause for the other identified failures.The service history has been reviewed in lieu of the device history record for this device since it was previously serviced.The device was last serviced on 06/18/2018 and passed all functional testing before being returned to the customer.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.Udi: (b)(4).Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that during service assessment 4580 fms duo+ pump/shaver combo device was identified as defective.No reported malfunction from the customer, no patient involvement, and no surgical delay.The failure was detected during electrical safety test.This is report 1 of 1 for complaint(b)(4).

• 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
• Manufacturer (Section G): 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: 9256990
• MDR Text Key: 207211798
• Report Number: 1221934-2019-59343
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705020607
• UDI-Public: 10886705020607
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K954465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 284580
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2019
• Date Manufacturer Received: 10/07/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1