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

Catalog Number 284580

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2019

Event Type  malfunction  

Manufacturer Narrative

(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.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 analysis.It was found that the right cover of the device was cracked.Also the second over-pressure was found to be too high.It was also noticed that the device was not calibrated correctly.The cover, being irreparable, was replaced.The unit was calibrated newly, cleaned, repaired and tested for functionality.The crack of the cover is most likely caused due to user mishandling.Improper calibration is one root cause for the excessive over-pressure, however, given the information provided we cannot discern a definitive root cause for the same.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 07/12/2018 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).

Event Description

It was reported by the fse via service request that during electrical safety test a defect has been identified in the fms duo+pump /shaver.No reported malfunction from the customer, no patient involvement, and no surgical delay.

• 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; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 9111242
• MDR Text Key: 203641564
• Report Number: 1221934-2019-58482
• 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: foreign
• Type of Report: Initial
• Report Date: 08/27/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: 284580
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2019
• Initial Date Manufacturer Received: 08/27/2019
• Initial Date FDA Received: 09/24/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1