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

Catalog Number BLACKMAX-N

Device Problem Air Leak (1008)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/27/2011

Event Type  malfunction  

Manufacturer Narrative

The device has been received by depuy synthes power tools.The investigation.Is still in process.(b)(4).

Event Description

Report received from usa stating that the device had an "air leak." it is known that the device was not used in surgery.It is not known if injuries or medical intervention occurred.There was no additional info provided.

• Brand Name: BLACKMAX-NEURO
• Type of Device: MOTOR, DRILL, PHEUMATIC - HANDPIECE
• 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: 5723049
• MDR Text Key: 48252230
• Report Number: 1045834-2013-05712
• Device Sequence Number: 1
• Product Code: HBB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K831756
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/27/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: BLACKMAX-N
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/04/2012
• Date Manufacturer Received: 12/27/2011
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1