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

Catalog Number BLACKMAX-N_LL

Device Problems Leak/Splash (1354); Device Slipped (1584)

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

Event Date 06/02/2016

Event Type  malfunction  

Manufacturer Narrative

Gtin is unavailable as the product was made prior to compliance date; (b)(4).The device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.Reliability engineering evaluated the device and observed that the cutter (mra) would not lock, oil leak from shift lever and the unit reflected low rotations per minute with a reading of 69,204 rpm's which is lower than the manufacturer's specification ((b)(4)).It was also noted tht the o-ring, spindle and pawls were worn out.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to wear from normal use and servicing.If additional information should become available, a supplemental medwatch report will be sent accordingly.

Event Description

It was reported that during service and repair pre-testing, it was observed that the motor device will not lock the cutter device, had an oil leak from the shift lever and rotations per minute (rpm) were below specification.The event was not related to surgery.There was no patient involvement reported.There were no injuries or medical intervention associated with this event.All available information has been disclosed.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: 5834406
• MDR Text Key: 52098203
• Report Number: 1045834-2016-12343
• 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: company representative,user f
• Reporter Occupation: Service and Testing Personnel
• Type of Report: Initial
• Report Date: 06/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: BLACKMAX-N_LL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/25/2004
• 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