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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK 4.0MM ULTRA-AGGRESSIVE BLADE PLUS, MICRO HUB; FMS ACCESSORIES
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DEPUY MITEK 4.0MM ULTRA-AGGRESSIVE BLADE PLUS, MICRO HUB; FMS ACCESSORIES 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 03/25/2015
Event Type  Injury  
Event Description
It was reported by the rep metal shavings were coming off of the shaver and deposited into the patients knee, during a knee scope.It is unknown how the procedure was completed and there were no patient consequences.Reported device will be returned.
 
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 of the device.
 
Manufacturer Narrative
The complaint device is not being returned, therefore unavailable for a physical evaluation.One possible hypothesis is that excessive friction between the inner and outer shafts could result in metal shaving, especially if the device has hit a hard surface during use.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.A white paper was performed previously on this failure; the result indicated that the amount of shedding for this product is acceptable.This file will remain receptive to any potential forthcoming information received that is pertinent and germane to this issue.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
It was reported by the rep metal shavings were coming off of the shaver and deposited into the patients knee, during a knee scope.It is unknown how the procedure was completed and there were no patient consequences.Reported device will be returned.Received the following information via email from the sales rep: the metal shaving were removed, he did not have the lot number for the blade but reported the blade was a 4.0mm ultra-aggressive blade plus, micro hub, product code 283429.
 
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Brand Name
4.0MM ULTRA-AGGRESSIVE BLADE PLUS, MICRO HUB
Type of Device
FMS ACCESSORIES
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
bahaa nashed
325 paramount drive
quality department
raynham, MA 02767
8003824682
MDR Report Key4725546
MDR Text Key5667059
Report Number1221934-2015-00715
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
PMA/PMN Number
K131191
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative,Distributor
Reporter Occupation Health Professional
Remedial Action Other
Type of Report Initial,Followup
Report Date 03/25/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/24/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number283429
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date03/25/2015
Event Location Hospital
Date Report to Manufacturer03/25/2015
Date Manufacturer Received03/25/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
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