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

Catalog Number EMAX2PLUS

Device Problems Break (1069); Device Slipped (1584); Naturally Worn (2988)

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

Event Date 08/29/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The actual device was returned for evaluation.Reliability engineering evaluated the device and the reported condition that the device was broken was confirmed.An assessment was performed on the device which found that the cutter would not lock onto the burr.During repair it was observed that the device a worn down lock cylinder, worn down pawls, and the modified screw on the motor retainer was broken.It was determined that the condition of the worn down lock cylinder and pawls was due to the failure to follow the directions for use (dfu) and running the device in the safe or load position, or with pushing down on the disconnect while the device.It was further determined that the condition of the broken modified screw was due to use of excessive force.The assignable root cause of this condition was determined to be component damage caused by user error.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Event Description

It was reported that during sterile processing it was observed that the motor device was broken.During in-house engineering evaluation it was found that the cutter would not lock onto the burr.During repair it was observed: that the device a worn down lock cylinder, worn down pawls, and the modified screw on the motor retainer was broken.The event was not related to surgery.It was not reported if there was a delay in a scheduled surgical procedure or if a spare device was available for use.There was no patient involvement reported.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: 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: 6050641
• MDR Text Key: 58605063
• Report Number: 1045834-2016-13041
• Device Sequence Number: 1
• Product Code: HBC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080802
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/30/2016

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: 09/08/2016
• Initial Date Manufacturer Received: 10/12/2016
• Initial Date FDA Received: 10/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/2010
• 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