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

Catalog Number BLACKMAX-N-LP

Device Problems Break (1069); Detachment Of Device Component (1104); Hole In Material (1293); Leak/Splash (1354)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(6) this device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.Reliability engineering evaluated the device and the reported condition was duplicated and confirmed.The assignable root cause was determined to be due to normal wear from use and servicing over time.If additional information should become available, a supplemental medwatch report will be sent accordingly.

Event Description

It was reported from (b)(6) that during service and evaluation, it was observed that the connector pins were coming apart, the bearings were damaged and there was a hole/cut in the hose on the motor device.It was reported in the service order that the device had an oil leak.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of this event was unknown.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: BLACKMAX-NEURO LOW PRESSURE
• 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 33410
• Manufacturer Contact: rodney crain ; 4500 riverside drive; palm beach gardens, FL 33410 ; 5616271080
• MDR Report Key: 5785175
• MDR Text Key: 50099733
• Report Number: 1045834-2016-12191
• Device Sequence Number: 1
• Product Code: HBB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K831756
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Service and Testing Personnel
• Type of Report: Initial
• Report Date: 06/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: BLACKMAX-N-LP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/27/2016
• Initial Date FDA Received: 07/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2004
• 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