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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK 5 MM BARREL TORNADO BUR PLUS FMS BLADES & BURRS

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DEPUY MITEK 5 MM BARREL TORNADO BUR PLUS FMS BLADES & BURRS Back to Search Results
Catalog Number 283889
Device Problem Material Fragmentation (1261)
Patient Problem No Information (3190)
Event Date 08/25/2016
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. Udi: (b)(4).
 
Event Description
The sales rep reported during a rcr procedure, the shaver was being used on the acromion, he was torquing the handle, but not more than usual. Metal shavings/particles were coming off the burr in excess. Used suction to clear the debris. There were no patient consequences. This delayed the procedure by five minutes.
 
Manufacturer Narrative
The complaint device was received and inspected. Visual observation of the complaint device reveals no anomalies to the outer shaft. When the inner shaft was examined, the distal end showed some friction marks, indicates excessive friction and indicates that the device might have hit a hard surface, which could lead to metal shavings as reported, confirming the complaint. It was reported that the metal shavings were produced when the user applied some torqueing on the device. 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 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. (b)(4).
 
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Brand Name5 MM BARREL TORNADO BUR PLUS
Type of DeviceFMS BLADES & BURRS
Manufacturer (Section D)
DEPUY MITEK
325 paramount drive
raynham MA 02767
Manufacturer Contact
jason busch
325 paramount drive
raynham, MA 02767
5088808210
MDR Report Key5981405
MDR Text Key55782056
Report Number1221934-2016-10402
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131191
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/30/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/27/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/31/2021
Device Catalogue Number283889
Device Lot NumberM1604047
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/21/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location Hospital
Date Report to Manufacturer08/30/2016
Date Manufacturer Received10/18/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/19/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 09/27/2016 Patient Sequence Number: 1
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