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U.S. Department of Health and Human Services

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

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DEPUY SYNTHES POWER TOOLS BLACKMAX-NEURO LOW PRESSURE; MOTOR, DRILL, PNEUMATIC - HANDPIECE Back to Search Results
Catalog Number BLACKMAX-N-LP
Device Problems Break (1069); Material Puncture/Hole (1504); Temperature Problem (3022)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
(b)(6).The device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.Reliability engineering evaluated the device and the reported condition was confirmed.The assignable root cause was determined to be due to strain/wear 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 by the (b)(6) that the handpiece device temperature was above specification.It was noted that the device was running too hot due to a worn motor.It was further noted that the hose was punctured, and locking was broken.The device also failed pre-repair diagnostic tests for initial rotational speed.This event did not occur during surgery.There was no patient involvement.There were no reports of 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.
 
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Brand Name
BLACKMAX-NEURO LOW PRESSURE
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 Key5582561
MDR Text Key43543795
Report Number1045834-2016-11364
Device Sequence Number1
Product Code HBB
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
PK831756
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Service and Testing Personnel
Type of Report Initial
Report Date 11/27/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberBLACKMAX-N-LP
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/01/2016
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 03/29/2016
Initial Date FDA Received04/15/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/31/2008
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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