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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 Decrease in Pressure (1490)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/02/2020
Event Type  malfunction  
Manufacturer Narrative
Product complaint #: (b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Investigation summary: the complaint device is not being returned, therefore unavailable for a physical evaluation. With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported failure. 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) 2019 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. However, depuy synthes 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. Initial reporter phone number: (b)(6). Udi: (b)(4).
 
Event Description
It was reported by the customer that during an unknown procedure, at irrigation point, the pump rotated all the while not inject water into the knee. As soon as it got into the knee, the pump no longer rotated properly. No consequence on the patient. No delay on the procedure. The procedure was completed with the pump. No further information available. Loaner request.
 
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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
325 paramount drive
raynham MA 02767
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6103142063
MDR Report Key10593063
MDR Text Key208758330
Report Number1221934-2020-02773
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K954465
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation
Type of Report Initial
Report Date 09/24/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/28/2020
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? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/24/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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