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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK FULL RADIUS CUTTER (LIGHT YELLOW) 3.5 MM FMS BLADES & BURRS

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DEPUY MITEK FULL RADIUS CUTTER (LIGHT YELLOW) 3.5 MM FMS BLADES & BURRS Back to Search Results
Catalog Number 283305
Device Problem Material Fragmentation (1261)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 09/05/2016
Event Type  Injury  
Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. (b)(4). The lot expiration date is currently unavailable.
 
Event Description
Surgeon was using 283305 (oscillate) to shave some tissue inside the ankle joint, then when he switched to forward, he noticed some metal debris coming out from the shaver when in contact with the bone. It appears unusual. Additional information received on 9-14-2016: the metal shavings were sucked out with shaver suction (as much as possible). The delay was probably about 10 mins, total procedure time was 50 mins.
 
Manufacturer Narrative
The complaint device was not returned and no further information has been provided about the device. In 2012, mitek analyzed the safety impact of metal particulate being left in the patient¿s joint space. The analysis encompasses reported complaints, device failure mode and effects analyses (fmea¿s), labeling, bench testing, surgeon inputs and published clinical literature. In this study, the amount of particulate generated by mitek instruments was compared against particulate amounts reported in published literature. Mitek devices were found to generate significantly less than what was reported in published literature. The review found that metal particulate generated from mitek instruments were found to occur at low levels without clinical consequences. With regard to the referenced complaint the most probable cause of metal shavings is the blade making contact with another instrument within the joint. Mitek blades and burrs are designed in a way to prevent metal on metal contact. Specifically, the rotating shafts are lubricated with biocompatible grease that should prevent metal on metal contact for the duration of the surgery. On rare circumstances such as extended or aggressive use, the blades may generate a small amount of fine metal particulate that is easily flushed from the joint space. A batch record review has been conducted and the 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 mitek complaints system revealed no other complaints of any kind for this lot of devices that were released to distribution. At this point in time, 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. (b)(4).
 
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Brand NameFULL RADIUS CUTTER (LIGHT YELLOW) 3.5 MM
Type of DeviceFMS BLADES & BURRS
Manufacturer (Section D)
DEPUY MITEK
325 paramount drive
raynham MA 02767
Manufacturer Contact
jennifer lawrence
325 paramount drive
raynham, MA 02767
5089776860
MDR Report Key6001919
MDR Text Key56536674
Report Number1221934-2016-10417
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K041824
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/05/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/05/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/28/2021
Device Catalogue Number283305
Device Lot NumberM1603042
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location Hospital
Date Report to Manufacturer09/05/2016
Date Manufacturer Received10/20/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/15/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 10/05/2016 Patient Sequence Number: 1
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