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

Catalog Number EMAX2

Device Problems Component Missing (2306); Cut In Material (2454); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913); Material Protrusion/Extrusion (2979)

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

Event Date 01/02/2015

Event Type  malfunction  

Event Description

It was reported that right before an unspecified surgical procedure started, it was observed that the inner hose of the motor device was exposed.During engineering evaluation, it was observed that the device had a cut in the cord exposing the wires, the cable and protective cap were missing from the connector, the device failed thermistor and had e8 error code.There were no delays to the planned surgical procedure as an identical spare device was available for use to successfully complete the procedure.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

The actual device was returned for evaluation.Reliability engineering evaluated the device and observed that the device had a cut in the cord exposing the wires, the cable and protective cap were missing from the connector, the device failed thermistor and had e8 error code.Therefore, the reported conditions were confirmed.It was determined that the cut in the cord and the missing protective cap and cable were caused by allowing the cord to come in contact with a sharp object.It was determined that the e8 error code was due to a worn thermistor.It was determined that the thermistor was worn from normal use and servicing over time.The assignable root cause was determined to be due to misuse, abuse and/or error.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: 4617097
• MDR Text Key: 21174552
• Report Number: 1045834-2015-10466
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/05/2015

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: 01/09/2015
• Initial Date Manufacturer Received: 02/24/2015
• Initial Date FDA Received: 03/19/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1