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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS PEDIATRIC CRANIOTOME MOTOR, DRILL, ELECTRIC ¿ CRANIOTOME
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DEPUY SYNTHES POWER TOOLS PEDIATRIC CRANIOTOME MOTOR, DRILL, ELECTRIC ¿ CRANIOTOME Back to Search Results
Catalog Number CRANI-P
Device Problem Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Malfunction  
Event Description

Report received from (b)(6) stating that the device had the condition of "frozen. " the device was not being used during surgery. It is unknown if there was injury or medical intervention. The date of the event is unknown. There was no additional information provided.

 
Manufacturer Narrative

The device was received by depuy synthes. The device is currently undergoing evaluation. Once the investigation has been completed or if additional information is received, a supplemental report will be sent. (b)(4).

 
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Brand NamePEDIATRIC CRANIOTOME
Type of DeviceMOTOR, DRILL, ELECTRIC ¿ CRANIOTOME
Manufacturer (Section D)
DEPUY SYNTHES POWER TOOLS
4500 riverside dr.
palm beach gardens FL 33410
Manufacturer (Section G)
DEPUY SYNTHES POWER TOOLS
4500 riverside dr.
palm beach gardens FL 33410
Manufacturer Contact
rodney crain
4500 riverside dr.
palm beach gardens, FL 33410
5614943766
MDR Report Key3593396
MDR Text Key4139224
Report Number1045834-2013-12427
Device Sequence Number1
Product Code HBC
Combination Product (Y/N)N
Reporter Country CodeIT
PMA/PMN NumberK011444
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Distributor
Reporter Occupation
Type of Report Initial
Report Date 01/13/2011
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/10/2013
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberCRANI-P
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer01/18/2011
Date Manufacturer Received01/13/2011
Was Device Evaluated By Manufacturer? No
Date Device Manufactured03/24/2006
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data

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