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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK 5 MM ULTRA AGGRESSIVE PLUS; BLADES & BURRS (CROSSCUT)
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DEPUY MITEK 5 MM ULTRA AGGRESSIVE PLUS; BLADES & BURRS (CROSSCUT) Back to Search Results
Catalog Number 283729
Device Problem Tip breakage (1638)
Patient Problem Unknown (for use when the patient's condition is not known) (2202)
Event Date 03/12/2015
Event Type  Injury  
Event Description
The ua+ blades was used to remove fiberwire when it showed metal flakes.The aggressive blade was used to remove parts of a torn acl.By the first introduction! it already showed metal flakes.The procedure was completed with same like product.Associated medwatch # 1221934-2015-00675.
 
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
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, 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 no other complaints of any kind for this lot of (b)(4) 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
The ua+ blades was used to remove fiberwire when it showed metal flakes.The aggressive blade was used to remove parts of a torn acl.By the first introduction! it already showed metal flakes.The procedure was completed with same like product.Associated medwatch # 1221934-2015-00675.
 
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Brand Name
5 MM ULTRA AGGRESSIVE PLUS
Type of Device
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 Key4663256
MDR Text Key5683372
Report Number1221934-2015-00676
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeNL
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
Report Date 03/13/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/07/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date04/30/2019
Device Catalogue Number283729
Device Lot NumberM1405018
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/03/2015
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date03/13/2015
Event Location Hospital
Date Report to Manufacturer03/13/2015
Date Manufacturer Received03/13/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/24/2014
Is the Device Single Use? Yes
Patient Sequence Number1
Patient Outcome(s) Other;
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