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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK TORNADO MICRO HANDPIECE WITH BUTTONS FMS EQUIPMENT

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DEPUY MITEK TORNADO MICRO HANDPIECE WITH BUTTONS FMS EQUIPMENT Back to Search Results
Catalog Number 283512
Device Problem Material Fragmentation (1261)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 10/27/2016
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).
 
Event Description
Dr. Was performing an acl. When he began using the shaver it made a loud screech upon pressing the on button and metal particles were shed apparently before hitting the bone with the burr. I did not witness this, however when i came in the room, dr. (b)(6) pointed out the particulate in the joint on the monitor. He continued using the burr to perform a notchplasty and when he finished this portion and turned off the hand piece, he said the hand piece was very warm to the touch, and that he had never felt that before. The warmth was felt on the portion of the hand piece above the outflow toggle to the shaver collar. The shaver particulate pieces were suctioned out with the shaver for the most part.
 
Manufacturer Narrative
The complaint device was received and evaluated. Visual observation under magnification does not indicate any anomalies on the device. There was no missing material observed on the hand piece that would indicate the reported metal particles would have come from the hand piece. The particles might have come off of the burr that was used. Excessive lateral force on the burr against a hard bone surface might be a probable root cause of this failure. The burr was not returned for evaluation. The hand piece was connected to an fms vue pump and tested. The hand piece functioned as intended. The hand piece was run for several minutes to ensure continuity of function. This complaint cannot be confirmed for the reported failure. A check of the manufacturing finished goods records for the reported batch number revealed no anomalies relating to the reported incident. There were no anomalies or discrepancies in the manufacture of this lot. A review into the depuy synthes mitek complaints system revealed no other complaints of any type for the serial number of this device. A root cause for the reported failure cannot be discerned. 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. (b)(4).
 
Event Description
Dr. Was performing an acl. When he began using the shaver it made a loud screech upon pressing the on button and metal particles were shed apparently before hitting the bone with the burr. I did not witness this, however when i came in the room, dr. (b)(6) pointed out the particulate in the joint on the monitor. He continued using the burr to perform a notchplasty and when he finished this portion and turned off the hand piece, he said the hand piece was very warm to the touch, and that he had never felt that before. The warmth was felt on the portion of the hand piece above the outflow toggle to the shaver collar. The shaver particulate pieces were suctioned out with the shaver for the most part.
 
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Brand NameTORNADO MICRO HANDPIECE WITH BUTTONS
Type of DeviceFMS EQUIPMENT
Manufacturer (Section D)
DEPUY MITEK
325 paramount drive
raynham MA 02767
Manufacturer Contact
jennifer lawrence
325 paramount drive
raynham, MA 02767
5089776860
MDR Report Key6123614
MDR Text Key60743310
Report Number1221934-2016-10504
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K954465
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 10/27/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/23/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number283512
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer11/10/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location Hospital
Date Report to Manufacturer10/27/2016
Date Manufacturer Received11/10/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/11/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 11/23/2016 Patient Sequence Number: 1
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