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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK LLC US FMS DUO+PUMP/SHAVER UNIT; DISTENSION UNIT, FLUID, ARTHROSCOPIC
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DEPUY MITEK LLC US FMS DUO+PUMP/SHAVER UNIT; DISTENSION UNIT, FLUID, ARTHROSCOPIC Back to Search Results
Model Number 284580
Device Problems Increase in Pressure (1491); Overfill (2404)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/28/2020
Event Type  malfunction  
Manufacturer Narrative
Udi: (b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
 
Event Description
It was reported by the sales rep that during a knee arthroscopy procedure on (b)(6) 2020, it was observed that the pressure was too high on the pump/shaver device that it would not stop filling the chamber on the device.The same device was used to complete the procedure without delay.There were no adverse patient consequences reported.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
 
Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.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.The reported complaint that the pressure is too high and nonstop filling of the chamber occurs while using the unit, was confirmed.It was found during evaluation that worn fingers on complete pressure adjusters is causing the reported pressure issue.There were also minor scratches on the device identified during decontamination.The service of the device was however declined and was placed into long-term hold as it was not needed for the equipment exchange pool use.The minor scratches on the device are most likely a result of user mishandling of the device.The worn fingers are a result of prolonged usage of the unit over time.There are no indications from this complaint investigation that the failures are manufacturing-related, therefore a manufacturing record evaluation is not required.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.
 
Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: d10, h3, h6: the actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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Brand Name
FMS DUO+PUMP/SHAVER UNIT
Type of Device
DISTENSION UNIT, FLUID, ARTHROSCOPIC
Manufacturer (Section D)
DEPUY MITEK LLC US
325 paramount drive
raynham MA 02767
MDR Report Key10831414
MDR Text Key215985727
Report Number1221934-2020-03459
Device Sequence Number1
Product Code HRX
UDI-Device Identifier10886705020607
UDI-Public10886705020607
Combination Product (y/n)N
PMA/PMN Number
K954465
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup,Followup,Followup
Report Date 10/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/12/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number284580
Device Catalogue Number284580
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/14/2020
Date Manufacturer Received12/15/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
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