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U.S. Department of Health and Human Services

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

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DEPUY MITEK LLC US 4580 FMS DUO+ PUMP/SHAVER COMBO LINE-POWERED ARTHROSCOPIC SHAVER SYSTEM Back to Search Results
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).
 
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Brand Name4580 FMS DUO+ PUMP/SHAVER COMBO
Type of DeviceLINE-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 Key8942556
MDR Text Key182767066
Report Number1221934-2019-58141
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K954465
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received08/28/2019
Is this a Product Problem Report? Yes
Device Operator
Device Model Number284580
Device Catalogue Number284580
Device Lot NumberF16A10858
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/15/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/30/2019
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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