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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK MITEK 3.5MM ULTRA-AGGRESSIVE SHAVER BLADES, 5PK; ARTHROSCOPIC SHAVER BLADES
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DEPUY MITEK MITEK 3.5MM ULTRA-AGGRESSIVE SHAVER BLADES, 5PK; ARTHROSCOPIC SHAVER BLADES Back to Search Results
Catalog Number 287325
Device Problem Unknown (for use when the device problem is not known) (2204)
Patient Problem Unknown (for use when the patient's condition is not known) (2202)
Event Date 10/15/2013
Event Type  Injury  
Event Description
Particulates release during the procedure, there was release of metallic debris in the joint.Intraoperative arthroscopic finding confirms the presence of metallic debris in the knee.Mitek complaints received this complaint report from our affiliate on (b)(6) 2014.
 
Manufacturer Narrative
Attempts have been made to retrieve additional information about the event and device.The additional information will reportedly be forwarded to mitek, however; mitek, would like to file this initial report at this time.When and if additional information is received it will be reflected in a follow-up report.In transit.
 
Manufacturer Narrative
The complaint device was received and evaluated.Visual observation indicates that the outer blade shaft was bent approximately 5-10 degrees indicating misuse.The inner blade showed no anomalies.Due to the fact that the outer blade is bent, when the blade is operated, there is increased friction between the inner and outer shaft which could lead to metal shavings as reported, confirming the complaint.The failure can be attributed to misuse.Furthermore, no lot numbers were supplied which precludes conducting a batch history review or a lot specific search in the complaints handling system.At this point in time, no corrective action is required and no further action is warranted.However, 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.
 
Event Description
Particulates release during the procedure, there was release of metallic debris in the joint.Intraoperative arthroscopic finding confirms the presence of metallic debris in the knee.Mitek complaints received this complaint report from our affiliate on (b)(6) 2014.
 
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Brand Name
MITEK 3.5MM ULTRA-AGGRESSIVE SHAVER BLADES, 5PK
Type of Device
ARTHROSCOPIC SHAVER BLADES
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 Key3709921
MDR Text Key4247904
Report Number1221934-2014-00107
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeFR
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
Report Date 11/07/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/28/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number287325
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/21/2014
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date11/07/2013
Event Location Hospital
Date Report to Manufacturer11/07/2013
Date Manufacturer Received11/07/2013
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Patient Sequence Number1
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