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

Catalog Number EMAX2PLUS

Device Problems Break (1069); Crack (1135); Naturally Worn (2988); Power Problem (3010)

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

Event Date 08/29/2016

Event Type  malfunction  

Manufacturer Narrative

Additional 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 device failed safety assessment (device running in the unlock position) (powerbroken).During repair it was found that the device had the flex circuit potting cracked, worn out lock cylinder, and a worn out pawl release.It was determined that the condition of the cracked flex circuit was due to normal wear over time.This issue has been escalated to capa.It was further determined that the cause of the device being powerbroken was due to failure to follow the directions for use (dfu) and running the device in the safe or load position and/or pushing down on the disconnect sleeve while the device.The assignable root cause of this condition was determined to be due to 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 device failed safety assessment (device running in the unlock position) (powerbroken).During repair it was found that the device had the flex circuit potting cracked, worn out lock cylinder, and a worn out pawl release.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: 6050647
• MDR Text Key: 58523469
• Report Number: 1045834-2016-13040
• 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: 10/10/2016
• Initial Date FDA Received: 10/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/24/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1