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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK 4 MM ULTRA AGGRESSIVE PLUS; MITEK FMS BLADES & BURRS (CROSSCUT)
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DEPUY MITEK 4 MM ULTRA AGGRESSIVE PLUS; MITEK FMS BLADES & BURRS (CROSSCUT) Back to Search Results
Catalog Number 283429
Device Problem Tip breakage (1638)
Patient Problem Unknown (for use when the patient's condition is not known) (2202)
Event Date 01/27/2015
Event Type  Injury  
Event Description
In the beginning of blade use, there was a huge amount of metal abrasion (debris) from the shaver blades going into the joint.Only part of it was removed.It was reported that the metal pieces were like snow powder.The surgeon said that we have a really imprecise way of manufacturing.
 
Manufacturer Narrative
Attempts have been made to retrieve additional information about the event and device.The additional information will reportedly be forwarded to depuy mitek however it is not known if it will be received within the 30 day reporting requirement, therefore, depuy mitek would like to file this initial medwatch report at this time.When and if additional information is received it will be reflected in a follow-up medwatch report.Awaiting return.
 
Manufacturer Narrative
The complaint device was received and forwarded to npd engineer for evaluation.Visual observation of the complaint device reveals no anomalies to the outer shaft.When the inner shaft was examined, signs of friction between the two shafts were seen.The friction marks indicates excessive friction, which could lead to metal shavings as reported.The returned complaint device was tested and was confirmed to shed metal shaving, confirming the complaint.A batch record review has been conducted to determine if there were any internal processing issues which would have contributed to the nature of the product complaint.Our results indicate that this batch of product was processed without incident and therefore there is no internally assignable cause for the reported problem.Further, a review into the depuy synthes mitek complaints system revealed one other dissimilar complaint for this lot of devices that were released to distribution.A white paper was performed previously on this failure; the result indicated that the amount of shedding for this product is acceptable.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.
 
Event Description
In the beginning of blade use, there was a huge amount of metal abrasion (debris) from the shaver blades going into the joint.Only part of it was removed.It was reported that the metal pieces were like snow powder.The surgeon said that we have a really imprecise way of manufacturing.
 
Manufacturer Narrative
This is a follow up report to document device return.A final report will be filed once the device has been investigated.
 
Event Description
In the beginning of blade use, there was a huge amount of metal abrasion (debris) from the shaver blades going into the joint.Only part of it was removed.It was reported that the metal pieces were like snow powder.The surgeon said that we have a really imprecise way of manufacturing.
 
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Brand Name
4 MM ULTRA AGGRESSIVE PLUS
Type of Device
MITEK FMS BLADES & BURRS (CROSSCUT)
Manufacturer (Section D)
DEPUY MITEK
325 paramount drive
quality department
raynham MA 02767
Manufacturer (Section G)
DEPUY MITEK
325 paramount drive
na
raynham MA 02767
Manufacturer Contact
eric so
325 paramount drive
quality department
raynham, MA 02767
8003824682
MDR Report Key4533648
MDR Text Key5543800
Report Number1221934-2015-00614
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K131191
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative,Distributor
Reporter Occupation Health Professional
Remedial Action Other
Type of Report Initial,Followup,Followup
Report Date 01/28/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/22/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date02/28/2019
Device Catalogue Number283429
Device Lot NumberM1403036
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/04/2015
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date01/28/2015
Device Age9 MO
Event Location Hospital
Date Report to Manufacturer01/28/2015
Date Manufacturer Received01/28/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/15/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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