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

Catalog Number EMAX2PLUS

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 04/08/2014

Event Type  malfunction  

Manufacturer Narrative

The actual device was returned for evaluation.Reliability engineering evaluated the device and the reported condition was not duplicated or confirmed.Therefore, an assignable root cause was not determined.If additional information should become available, a supplemental medwatch report will be sent accordingly.

Manufacturer Narrative

As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If additional information should become available, a supplemental medwatch report will be sent accordingly.

Event Description

This is report 3 of 3 for the same event.It was reported that during pre-surgery setup for a makoplasty knee surgery, it was discovered that the hose of the motor device left a black residue when it was cleaned, had an oily feeling, and it seemed the rubber hose was breaking down.The reporter stated that ¿this has occurred ever since the drill was received¿.The reporter clarified that the black residue was in a powder form¿.The reporter believed that the ¿report of oily feeling was from the lubricant used during the cleaning process¿.A spare identical device was available but had the same alleged deficiency.A second spare identical device was available but also had the same alleged deficiency.One of the three devices was reportedly sterilized by a "flash or cook procedure" and was used to complete the surgery successfully.The reporter could not clarify which device was used in the surgery.There was a delay of fifteen minutes to the planned surgical procedure due to the set-up for the spare identical devices.The patient remained in the pre-op holding room.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: 3787240
• MDR Text Key: 12223063
• Report Number: 1045834-2014-11984
• Device Sequence Number: 1
• Product Code: HBC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK080802
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/24/2014

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: EMAX2PLUS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/27/2014
• Initial Date FDA Received: 05/02/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/03/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/02/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1