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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 Electrical /Electronic Property Problem (1198)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
It was reported by the affiliate in (b)(6) that during service evaluation, it was determined that the fms duo®+pump/shaver unit device failed the electrical safety test. There was no procedure nor patient involvement reported. No additional information was provided.
 
Manufacturer Narrative
Additional narrative: udi: (b)(4). Investigation summary: the device was received at the service center and evaluated. There was no allegation of malfunction against the device from the customer, however, defects were found with the device during service evaluation. This complaint can be confirmed. During the service evaluation the following defects were identified: both covers are damaged. Unit is not calibrated correctly, valve irreparable: replaced, physical damage: pressure valve irreparable: replaced, the plug for connecting of the handpiece is defective -corrosion, missing component right- lexan safety cover with hinges and failure-luer lock. The plug, cover and pressure valve were replaced and unit calibrated to resolve the issues. After repair, the device was found to be working according to the specifications. The faulty parts was identified as the root cause for the device failure during the service evaluation. Manufacturing record evaluation is not required as the reported event is not associated with the manufacturing process and/or the potential cause of the defect cannot be associated to manufacturing. 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.
 
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Brand NameFMS DUO®+PUMP/SHAVER UNIT
Type of DeviceDISTENSION UNIT, FLUID, ARTHROSCOPIC
Manufacturer (Section D)
DEPUY MITEK LLC US
325 paramount drive
raynham MA 02767
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6103142063
MDR Report Key13003590
MDR Text Key285006457
Report Number1221934-2021-03731
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodePL
PMA/PMN Number
K954465
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation
Type of Report Initial
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/14/2021
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 Manufacturer12/03/2021
Date Manufacturer Received12/07/2021
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 Unkown
Removal/Correction NumberN/A

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