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

Catalog Number EMAX2

Device Problems Detachment Of Device Component (1104); Material Protrusion/Extrusion (2979)

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

Event Date 12/23/2014

Event Type  malfunction  

Event Description

It was reported that at the end of an unspecified ear surgical procedure, it was observed that the rubber came apart from the handpiece of the motor device and wires were exposed.There were no delays to the surgical procedure.It was reported that a spare device was not needed as the alleged malfunction occurred after the surgery was already completed.There was 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.

Manufacturer Narrative

Additional narrative: as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

The actual device was returned for evaluation.Reliability engineering evaluated the device and observed that the device had a torn cord and wires were exposed.It was further observed that the connector body was loose and the thermistor failed.Therefore, the reported condition was confirmed.It was determined that the cord was torn due to excessive force on the cord.It was determined that the loose connector was due to loctite deterioration.It was determined that the thermistor failed because the component was worn.The assignable root cause was determined to be due to normal wear over time.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: EMAX 2 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: 4432946
• MDR Text Key: 5387806
• Report Number: 1045834-2015-10089
• Device Sequence Number: 1
• Product Code: HBC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK011444
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/23/2014

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: EMAX2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/27/2015
• Initial Date FDA Received: 01/20/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1