MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS PEDIATRIC CRANIOTOME MOTOR, DRILL, ELECTRIC ¿ CRANIOTOME

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  

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).

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.

• Brand Name: PEDIATRIC CRANIOTOME
• Type of Device: MOTOR, 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 Key: 3593396
• MDR Text Key: 11536016
• Report Number: 1045834-2013-12427
• Device Sequence Number: 1
• Product Code: HBC
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K011444
• Number of Events Reported: 1
• 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 Received: 09/10/2013
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: CRANI-P
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/18/2011
• Date Manufacturer Received: 01/13/2011
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/24/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Invalid Data