MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS EMAX 2 PLUS MOTOR; MOTOR, DRILL, ELECTRIC - HANDPIECE

Catalog Number EMAX2PLUS

Device Problems Crack (1135); Hole In Material (1293); Incorrect Or Inadequate Test Results (2456); Naturally Worn (2988)

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

Event Type  malfunction  

Manufacturer Narrative

Udi: (b)(4).Initial reporter¿s phone number: (b)(6).The actual device was returned for evaluation.Reliability engineering evaluated the device and determined that the device had a hole in the cord, and failed safety assessment (running in the lock position).It was further determined that the locking cylinder and pawl release were worn down; and the flex circuit potting was cracked.It was determined that the worn down lock cylinder and pawl release were consistent with excessive force by pushing down on the disconnect while the device was running.It was determined that the cracked flex circuit was consistent with normal wear over time.It was determined that the hole in the cord was consistent with mishandling of the device by allowing the cord to come into contact with a sharp object which punctured the cord or exerting extreme force on the cord during cleaning or use.The assignable root causes were determined to be due to user error and wear from normal 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 the motor device had a hole in the insulation.During an in-house engineering evaluation, it was observed that the device had a hole in the cord, and failed safety assessment (running in the lock position).It was further determined that the locking cylinder and pawl release were worn down; and the flex circuit potting was cracked.It was not reported whether the event occurred during surgery or whether there was patient involvement.It was not reported whether there were delays in the surgical procedure or if a spare device was available for use.It was not reported if there were any 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: EMAX 2 PLUS MOTOR
• Type of Device: MOTOR, DRILL, ELECTRIC - 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: 6069367
• MDR Text Key: 59023117
• Report Number: 1045834-2016-13095
• Device Sequence Number: 1
• Product Code: HBC
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K080802
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/15/2016

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: EMAX2PLUS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2016
• Initial Date Manufacturer Received: 10/17/2016
• Initial Date FDA Received: 11/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/28/2014
• 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