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

Catalog Number EMAX2PLUS

Device Problems Naturally Worn (2988); Power Problem (3010); Noise, Audible (3273)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The actual device was returned for evaluation.Reliability engineering evaluated the device and the reported condition that the device was noisy was not confirmed.However, during evaluation it was observed that an unauthorized repair had been performed on the cable ((b)(4)) and the device ran in the load position (power broken).It was further observed that the pawl release castellations were worn out.It was determined that the device being power broken was 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 of this condition 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 the motor device was noisy.During in-house engineering evaluation it was found that an unauthorized repair had been performed on the cable and the device ran in the load position (power broken).It was further observed that the pawl release constellations were worn out.The event was not reported to have occurred during a surgical procedure.It was not reported if there were any delays to a scheduled surgical procedure, or if a spare device was available for use.There was no patient involvement reported.There were no patient or user injuries reported.It was reported there was no 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: 5952850
• MDR Text Key: 55171941
• Report Number: 1045834-2016-12732
• Device Sequence Number: 1
• Product Code: HBC
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 07/11/2016

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: 09/07/2016
• Initial Date Manufacturer Received: 09/12/2016
• Initial Date FDA Received: 09/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/20/2009
• 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