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U.S. Department of Health and Human Services

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

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DEPUY SYNTHES POWER TOOLS BLACKMAX-NEURO; MOTOR, DRILL, PNEUMATIC - HANDPIECE Back to Search Results
Catalog Number BLACKMAX-N
Device Problem Air Leak (1008)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/10/2013
Event Type  malfunction  
Event Description
It was reported that during an unspecified surgical procedure it was discovered that there was an "air leak" in the hose of the motor device.It was unknown to the reporter if the leak was proximal or distal to the motor device.There were no delays to the planned surgical procedure as a spare identical device was available for use.The reporter indicated that the "patient was not affected." no patient harm, adverse outcome or injury was alleged.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
 
Manufacturer Narrative
The actual device was returned for evaluation.  (b)(4) evaluated the device and the reported condition was not duplicated or confirmed.  therefore, an assignable root cause was not determined.  if additional information should become available, a supplemental medwatch report will be submitted accordingly.
 
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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 Contact
rodney crain
4500 riverside drive
palm beach gardens, FL 33410
5616271080
MDR Report Key3553068
MDR Text Key17952712
Report Number1045834-2013-36585
Device Sequence Number1
Product Code HBB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK831756
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Nurse
Type of Report Initial
Report Date 12/11/2013
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
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/12/2013
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/11/2013
Initial Date FDA Received01/06/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/11/2008
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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