MAUDE Adverse Event Report: DEPUY MITEK LLC US 4580 FMS DUO+ PUMP/SHAVER COMBO; LINE-POWERED ARTHROSCOPIC SHAVER SYSTEM

Model Number 284580

Device Problems Break (1069); Pressure Problem (3012)

Patient Problem No Patient Involvement (2645)

Event Date 01/01/2019

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: investigation summary: the device was received and evaluated at the service center.There was no specific complaint or a defect description from the customer, however, defects were found with the device during repair analysis.It was found that the suction cover was broken and the overpressure was out of range.The cpu board was found to be defective.The cpu board was repaired and the suction cover was replaced as it was irreparable.The device was cleaned, repaired and tested for functionality.The defective cpu board is responsible for the over-pressure being out of range while the broken suction cover is a result of user mishandling.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 04/19/2017 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.Device history lot 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 04/19/2017 and passed all functional testing before being returned to the customer.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 via service request that the fms duo pump came in for [preventative maintenance.A complaint was escalated from a wo due to a defect identified during service assessment.No reported malfunction from the customer, no patient involvement, and no surgical delay.The failure was detected during electrical safety test.This report is 1 of 1 for (b)(4).

• Brand Name: 4580 FMS DUO+ PUMP/SHAVER COMBO
• Type of Device: LINE-POWERED ARTHROSCOPIC SHAVER SYSTEM
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): FMS
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 8942556
• MDR Text Key: 182767066
• Report Number: 1221934-2019-58141
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705020607
• UDI-Public: (01)10886705020607
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K954465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 284580
• Device Catalogue Number: 284580
• Device Lot Number: F16A10858
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/30/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1