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

Catalog Number EMAX2PLUS

Device Problems Failure To Adhere Or Bond (1031); Cut In Material (2454); Positioning Problem (3009)

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

Event Date 10/12/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).The actual device was returned for evaluation.Reliability engineering evaluated the device and the reported condition was confirmed.An assessment was performed on the device which found that there was a cut in the cord, and the device ran and the cutter rotated in the load (safe) position (power broken).During repair it was observed that the castellations on the pawl release and lock cylinder were worn down.It was determined that the cut/hole in cord is due to mishandling of the device by allowing the cord to come in contact with a sharp object which punctured the cord or exerting extreme force on the cord during cleaning or use.It was further determined that the device being power broken was caused by worn castellations on the pawl release and lock cylinder.The worn pawl release and lock cylinder castellations are caused by trying to operate the device in the load position or by pushing down on the disconnect sleeve while the device is in operation.The assignable root cause was determined to be due to 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 from (b)(6) that during maintenance and testing it was observed that the motor device knurled knob would not secure.During pre-repair diagnostic assessment, it was found that there was a cut in the cord, and the device ran and the cutter rotated in the load (safe) position (power broken).During repair it was also observed that the castellations on the pawl release and lock cylinder were worn down.The event was not related to surgery.It was reported that there was no delay to a scheduled procedure and an identical 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: 6113626
• MDR Text Key: 60846379
• Report Number: 1045834-2016-13270
• Device Sequence Number: 1
• Product Code: HBC
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K080802
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2016
• 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: 10/28/2016
• Date Manufacturer Received: 11/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2013
• 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