MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS BLACKMAX-NEURO; MOTOR, DRILL, PNEUMATIC - HANDPIECE

Catalog Number BLACKMAX-N

Device Problem Pressure Problem (3012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Please note that the incorrect brand name, common device name, device product code and 510k were inadvertently inserted into the initial medwatch report.These sections have been updated with the correct product information.Device evaluation: the actual device was returned for evaluation.Reliability engineering evaluated the device and observed that the hose had cut/hole in it, the rotations per minute (rpm) were below specification causing low power, and the bearings were becoming stiff.Therefore, the reported condition was confirmed.The assignable root cause was due to the device being worn from normal use and servicing over time.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Event Description

It was reported from italy that the motor device was losing air.It was not reported if the device was used in surgery, or if there was patient involvement.It was not reported if there were any delays in a surgical procedure or if a spare device was available.It was not reported if there were any injuries, medical intervention or prolonged hospitalization.The exact date of this event was unknown.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: BLACKMAX-NEURO
• Type of Device: MOTOR, DRILL, PNEUMATIC - HANDPIECE
• Manufacturer (Section D): DEPUY SYNTHES POWER TOOLS; 4500 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): DEPUY SYNTHES POWER TOOLS; 4500 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: rodney crain ; 4500 riverside drive; palm beach gardens, FL 33410 ; 5616271080
• MDR Report Key: 4617698
• MDR Text Key: 13422696
• Report Number: 1045834-2015-10434
• Device Sequence Number: 1
• Product Code: HBB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK831756
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: BLACKMAX-N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/1996
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1