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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK 5.0 MM BARREL BURR PLUS MITEK BLADES & BURRS

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DEPUY MITEK 5.0 MM BARREL BURR PLUS MITEK BLADES & BURRS Back to Search Results
Catalog Number 283869
Device Problem Material Fragmentation (1261)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/25/2016
Event Type  malfunction  
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). The lot expiration date is currently unavailable.
 
Event Description
Small tiny bit of metal was ripped away from the burr event date: unknown. Photos available, will send once we get the official ref nr. Additional information received via email from the affiliate on (b)(6) 2016 type of procedure was mitek surgery, but what exactly the surgery was is unknown all the metal shavings were removed, but not sure what was used to remove them delay of 5 minutes.
 
Manufacturer Narrative
The complaint device was received and evaluated. Visual observation under magnification of the complaint device reveals that the corner of the distal end of the outer shaft has a small piece of the corner missing. Also there is marking on the inside of the sleeve which indicates that a strong lateral force was placed on the burr causing it to rub against the inner sleeve. This caused excessive friction and indicates that the device might have hit a hard surface, which could lead to metal shavings as reported. The doctor and the affiliate were contacted that reported this complaint and they indicated that the device may have gotten stuck between some bones during the operation. This complaint can be confirmed. A dhr 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 type for this lot of 40 devices that were released to distribution. 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. Udi: (b)(4).
 
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Brand Name5.0 MM BARREL BURR PLUS
Type of DeviceMITEK 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 Key6119275
MDR Text Key60655891
Report Number1221934-2016-10499
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 10/25/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/21/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2021
Device Catalogue Number283869
Device Lot NumberM1605038
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/21/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location Hospital
Date Report to Manufacturer10/25/2016
Date Manufacturer Received01/12/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/04/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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