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

Catalog Number EMAX2PLUS

Device Problem Failure to Advance (2524)

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

Event Date 05/11/2016

Event Type  malfunction  

Manufacturer Narrative

Reporter's complete address and phone number were not provided.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported from (b)(6) that during an unspecified surgical procedure, it was observed that the motor device would not work continuously.According to the report, the device would not pierce through the bone.It was not reported if there were any delays in the surgical procedure or if a spare device was available for use.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 did not run and displayed an e8 error.It was further observed that the two wires were pinched in the connector and the hall sensor 3 failed.It was determined that the issues were consistent with improper assembly of the handpiece connector.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to improper assembly / manufacture.This issue has been escalated to capa.If information is obtained that was not available, a follow-up medwatch will be filed as appropriate.

• Brand Name: EMAX 2 PLUS HANDPIECE
• 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: 5682028
• MDR Text Key: 46010191
• Report Number: 1045834-2016-11805
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EMAX2PLUS
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/05/2016
• 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