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

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.

• Brand Name: TORNADO MICRO HANDPIECE WITH BUTTONS
• Type of Device: FMS 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 Key: 6123614
• MDR Text Key: 60743310
• Report Number: 1221934-2016-10504
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K954465
• Number of Events Reported: 1
• 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 Received: 11/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: 283512
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/10/2016
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: Hospital
• Date Report to Manufacturer: 10/27/2016
• Date Manufacturer Received: 11/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2016
• 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