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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 -NS DISTENSION UNIT, FLUID, ARTHROSCOPIC

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DEPUY MITEK LLC US 4580 FMS DUO+ PUMP/SHAVER COMBO -NS DISTENSION UNIT, FLUID, ARTHROSCOPIC Back to Search Results
Model Number 284580
Device Problem Mechanical Jam (2983)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
(b)(4). 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 covers were damaged and one tension rocker arm was sticking. The insertion lever was defective and the unit was not calibrated correctly. The defective insertion lever along with the irreparable cover was replaced and the device was cleaned, newly calibrated, tested and found to be working according to specifications. User mishandling is one possible root cause of the damage to the covers and would have possibly caused the damage to the other defective components. 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 (b)(6) 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.
 
Event Description
It was reported from (b)(6) that during service and repair, it was determined that the 4580 fms duo+ pump/shaver combo -ns device had a defective insertion lever. This event did not occur during surgery. There was no patient involvement. There were no reports of injuries, medical intervention or prolonged hospitalization. All available information has been disclosed. If additional information should become available, a supplemental medwatch will be submitted accordingly.
 
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Brand Name4580 FMS DUO+ PUMP/SHAVER COMBO -NS
Type of DeviceDISTENSION 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
6013142063
MDR Report Key10507189
MDR Text Key208018797
Report Number1221934-2020-02418
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K954465
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 08/19/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/09/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number284580
Device Catalogue Number284580
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/02/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/19/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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