Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK LLC US ULTRA AGGRESSIVE PLUS 5.0 5PK; ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DEPUY MITEK LLC US ULTRA AGGRESSIVE PLUS 5.0 5PK; ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE Back to Search Results
Model Number 283729
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/09/2020
Event Type  malfunction  
Manufacturer Narrative
Product complaint #: (b)(4).Udi: (b)(4).
 
Event Description
It was reported the terminal releases metal when it rotates.The surgery was not delayed and no patient consequences occurred.The case was completed with another cutter and additional surgical intervention was not required.
 
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: investigation summary: according to the investigation provided, it was reported that the terminal releases metal when it rotates.The device was received and evaluated in juarez lab.It was observed that the tip between the outer and inner had marks of wear.The photo provided by the customer showed the outer section with some biological residues.The device was sent to r&d for further investigation.The investigation began with having the operations team investigated the manufacturing facility where the blades are made and to review dhr¿s for obvious deviations or anomalies.The operations team concluded that there were no obvious deviations to be concerned with.The investigation was divided into three stages, complaint blade inspection, spring force testing, o-ring testing.Since there were signs of wear and discoloration detected on the blades, the team decided to randomly select complaint blades to be inspected for out of specification tolerances.A doe was constructed to test the three factors to see which have the largest effect on shedding.A tolerance analysis was conducted on the handpiece with blade assembly to find the maximum and minimum values for the gap where an acceptable amount of shedding is allowed.The test was conducted following the shed test method using eight blades alternating the following parameters: material type, speed, and spring force.In conclusion, the results show that the factor direction is above the specification, therefore it has the largest effect on shaver shedding of the three factors.Although factor of spring force is below the mark it was investigated since it is a factor that can be controlled while direction is based on surgeon discretion.The results conclude that the material does not have a significant effect on the shedding and that a higher amount of shedding occurs when the spring force is increased, and the shaver blade is run at higher speeds (6,000 rpm).Also, a sample was ran for 30 seconds, sample two was ran for 60 seconds, and sample three was ran for 60 seconds.The test results concluded that if there is a significant amount of shedding it will occur in the first 30 seconds and not gradually over time.In addition, after discovering that some handpieces were missing the o-ring in the front of the handpiece, a test was conducted to determine how this could affect shedding.As seen in the results shedding can be reproduced, but with the o-ring present and proper spring force maintained, the amount of shedding is significantly decreased.Based on the investigation potential ways to reduce shedding is to ensure all handpieces are properly serviced and maintained to ensure the presence of the o-ring.During the servicing make sure tissue seal spring is properly placed and that no debris is caught on or under the tissue seal spring, which could cause an increase in the spring force.Continue to monitor and inspect the handpiece usage in the region and verify that the decontamination and cleaning processes are following the proper ifu.Another potential way to reduce shedding is to run the blades at a lower speed and in oscillation direction as shown in the test results.As this complaint rate falls within the expected occurrence rate per the dfmea, no further risk reduction actions are 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.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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ULTRA AGGRESSIVE PLUS 5.0 5PK
Type of Device
ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE
Manufacturer (Section D)
DEPUY MITEK LLC US
325 paramount drive
raynham MA 02767
MDR Report Key10590837
MDR Text Key208715408
Report Number1221934-2020-02760
Device Sequence Number1
Product Code HRX
UDI-Device Identifier10886705022083
UDI-Public10886705022083
Combination Product (y/n)N
PMA/PMN Number
K041824
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 09/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/25/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number283729
Device Catalogue Number283729
Device Lot NumberM1905013
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/16/2020
Date Manufacturer Received12/29/2020
Patient Sequence Number1
-
-