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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
Catalog Number 284580
Device Problems Increase in Pressure (1491); Pressure Problem (3012)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/01/2018
Event Type  malfunction  
Manufacturer Narrative
If additional information should become available, a supplemental medwatch will be submitted accordingly.Udi: (b)(4).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 additional information should become available, a supplemental medwatch report will be submitted accordingly.
 
Event Description
It was reported by the affiliate in (b)(6) that during service and repair, it was determined that the 4580 fms duo+ pump/shaver combo -ns device had an excessive pressure which resulted from the following defects: cpu board, cover, valve, and holder for compressed air reservoir.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of the event was unknown but was noted to have occurred in 2018.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
 
Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, 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 complaint device was received at service center for preventive maintenance.There were deficiencies found impairing the function of the device.The irreparable cover was replaced, cpu board was repaired, the irreparable holder for compressed air reservoir was replaced, other defective materials were exchanged and the irreparable pinch valve irreparable was replaced.Device mishandling is the possible root cause for broken cover, bent pinch valve, bent chamber holder and bent guide line.Normal wear of the pressure adjuster is the possible root cause for the excessive pressure.The device was manufactured by a facility which has been closed since 2011, therefore a review of lot/batch history for each legacy fms product complaint is not possible since legacy manufacturing no longer exists, and it is no longer possible to make process corrections or corrective actions.At this point in time, 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.Udi: (b)(4).
 
Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).Corrected data: date device returned to manufacturer.
 
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Brand Name
4580 FMS DUO+ PUMP/SHAVER COMBO -NS
Type of Device
DISTENSION UNIT, FLUID, ARTHROSCOPIC
Manufacturer (Section D)
DEPUY MITEK LLC US
325 paramount drive
raynham MA 02767
MDR Report Key8209571
MDR Text Key131840030
Report Number1221934-2019-55886
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,foreig
Type of Report Initial,Followup,Followup
Report Date 12/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number284580
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/11/2018
Initial Date Manufacturer Received 12/13/2018
Initial Date FDA Received01/02/2019
Supplement Dates Manufacturer Received01/02/2019
01/11/2019
Supplement Dates FDA Received01/03/2019
01/14/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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