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

Catalog Number BLACKMAX-N

Device Problem Device Stops Intermittently (1599)

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

Event Date 04/28/2016

Event Type  malfunction  

Manufacturer Narrative

The actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.

Event Description

It was reported that during an unspecified surgical procedure it was observed that the handpiece device had intermittent operation.It was noted that the handpiece operated only part of the time.It was reported that there was no delay in the procedure as an unspecified spare device was available for use.There were no patient or user injuries reported.It was reported there was no medical intervention or prolonged hospitalization.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.Reliability engineering evaluated the device and identified no failure.It was determined that the device passed all operational specifications.Therefore, the reported condition was not confirmed.An assignable root cause was not determined.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• 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 Key: 5647423
• MDR Text Key: 45054695
• Report Number: 1045834-2016-11701
• Device Sequence Number: 1
• Product Code: HBB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK831756
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 05/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2016
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/08/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/14/2002
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1