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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 Device Stops Intermittently (1599)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
It was reported that during a hip revision surgery, it was discovered that the motor device ¿worked intermittently¿.The reporter clarified that the device ¿would not grip the burr¿.There were no delays to the scheduled surgical procedure.It was unknown if a spare device was available for use.There were no reports of injuries, medical intervention or prolonged hospitalization.The date of the 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
Additional narrative: the actual device was returned for evaluation.Reliability engineering evaluated the device.The device was tested and it was found that the device would not secure cutter.Therefore, the reported condition was duplicated and confirmed.The assignable root cause was determined to be normal wear over time.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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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 (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 Key3675344
MDR Text Key4242356
Report Number1045834-2014-11548
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 User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 02/18/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/12/2014
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 Manufacturer02/24/2014
Date Manufacturer Received02/18/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/28/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
CUTTER DEVICE
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