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

Catalog Number EMAX2PLUS

Device Problems Break (1069); Corroded (1131); Loose or Intermittent Connection (1371); Naturally Worn (2988); Noise, Audible (3273)

Patient Problem No Patient Involvement (2645)

Event Date 08/26/2016

Event Type  malfunction  

Manufacturer Narrative

Udi: (b)(4).Initial reporter¿s phone number: (b)(6).This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.Reliability engineering evaluated the device and the reported condition was confirmed.The assignable root cause was determined to be due to excessive wear from normal use and servicing.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 had an undetermined malfunction.During the pre-repair diagnostics assessment, it was observed that the locking components were badly damaged and the device was worn.It was further determined that the swivel was corroded and the housing was dented.It was observed that the device had loose pins and made too much noise.It was further determined that the device failed for noise assessment and for safety assessment.This event did not occur during surgery.There were no delays in a surgical procedure as a spare device was available.There was no 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.

• 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: 6016396
• MDR Text Key: 57457357
• Report Number: 1045834-2016-12910
• Device Sequence Number: 1
• Product Code: HBC
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 08/26/2016

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
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2016
• Initial Date Manufacturer Received: 09/21/2016
• Initial Date FDA Received: 10/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/03/2009
• 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