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

Catalog Number BLACKMAX-N_LL

Device Problems Break (1069); Device Slipped (1584)

Patient Problem No Patient Involvement (2645)

Event Date 09/16/2016

Event Type  malfunction  

Manufacturer Narrative

Gtin is unavailable as the product made prior to compliance date; (b)(4).The actual device was returned without an alleged deficiency.During routine service and repair of the device, it was observed that the device was powerbroken (runs in the load position), had a loose ring gear, and had an internal rub.It was determined that the condition of the device being powerbroken was due to the device being run in the load positon, which is user error.It was further determined that the condition of the ring gear and internal rub was due to normal wear over time.The assignable root cause was determined to be component damage due to user error and wear from normal use and servicing over time.It was noted that the failure was caused by worn out motor components.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Event Description

It was reported that during service and repair/pre-testing, it was observed that the handpiece device was power broken, had a loose ring gear, and internal rub.The event was not related to surgery.There was no patient involvement.There were no reports of injuries, 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.

• 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: 6030212
• MDR Text Key: 57712863
• Report Number: 1045834-2016-12961
• 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,health
• Reporter Occupation: Service and Testing Personnel
• Type of Report: Initial
• Report Date: 09/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: BLACKMAX-N_LL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2008
• 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