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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 Problem Increase in Pressure (1491)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/18/2021
Event Type  malfunction  
Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Additional 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 shoulder repair procedure on (b)(6) 2021, it was observed that the outflow is not working on the fms duo® pump/shaver unit device.Another like device was used to complete the procedure with a delay of approximately 10 minutes.There were no adverse patient consequences reported.No additional information was provided.
 
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.H11 additional narrative: investigation summary: the complaint device was received at the service center and evaluated.The reported complaint that the outflow was not working on the pump, was confirmed.It was found that the pump was damaged and had no/low flow.Further, minor scratches were identified on the device during evaluation.However the service was declined and the device was placed into long-term hold.Broken doors can be the possible root cause of the reported failure.User mishandling and/or lack of maintenance can be the most probable root causes of the broken doors and scratches in the device.The potential cause for this issue is not related to manufacturing, therefore a manufacturing record evaluation is not required.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.
 
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.The actual device has been returned and is currently pending evaluation.Once the device has been evaluated, 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 Key11399950
MDR Text Key234287607
Report Number1221934-2021-00717
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
Report Date 02/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/02/2021
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 Manufacturer03/02/2021
Date Manufacturer Received03/05/2021
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
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