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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK MINI FULL RADIUS CUTTER (LIGHT YELLOW) 2; NEXTRA FMS BLADES & BURRS
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DEPUY MITEK MINI FULL RADIUS CUTTER (LIGHT YELLOW) 2; NEXTRA FMS BLADES & BURRS Back to Search Results
Catalog Number 283205
Device Problem Tip breakage (1638)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/06/2014
Event Type  malfunction  
Event Description
During a shoulder arthroscopy the mini full radius cutter generated metal debris.All particles have been removed with a grasper and cleaning again afterwards.Surgery was completed with same like product.All shavers with the same lot have been returned to check.No further issues.
 
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.
 
Manufacturer Narrative
Attempts have been made to retrieve additional information about the event and device.Device is under investigation.When and if additional information is received it will be reflected in a follow-up medwatch report.
 
Event Description
During a shoulder arthroscopy the mini full radius cutter generated metal debris.All particles have been removed with a grasper and cleaning again afterwards.Surgery was completed with same like product.All shavers with the same lot have been returned to check.No further issues.
 
Manufacturer Narrative
The complaint device was received and evaluated.Six unused devices and one used device were received.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, confirming the complaint.The six unused devices were examined and no anomalies were observed with them.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 no other complaints of any type for these lots of (b)(4) devices that were released to distribution in 2010.Moreover, no other complaints were found for this product code for (2014-2015).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
During a shoulder arthroscopy the mini full radius cutter generated metal debris.All particles have been removed with a grasper and cleaning again afterwards.Surgery was completed with same like product.All shavers with the same lot have been returned to check.No further issues.
 
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Brand Name
MINI FULL RADIUS CUTTER (LIGHT YELLOW) 2
Type of Device
NEXTRA FMS BLADES & BURRS
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
david primmerman
325 paramount drive
quality department
raynham, MA 02767
8003824682
MDR Report Key4221296
MDR Text Key5075433
Report Number1221934-2014-00477
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K954465
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 10/06/2014
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 Expiration Date03/31/2015
Device Catalogue Number283205
Device Lot Number0938A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/08/2014
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date10/06/2014
Device Age54 MO
Event Location Hospital
Date Report to Manufacturer10/06/2014
Initial Date Manufacturer Received 10/06/2014
Initial Date FDA Received11/03/2014
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Supplement Dates FDA Received12/19/2014
06/18/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/12/2010
Is the Device Single Use? Yes
Patient Sequence Number1
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