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

Catalog Number EMAX2

Device Problems Corroded (1131); Defective Component (2292); Incorrect Or Inadequate Test Results (2456); Device Operates Differently Than Expected (2913); Naturally Worn (2988); Physical Property Issue (3008)

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

Event Date 08/08/2016

Event Type  malfunction  

Manufacturer Narrative

Udi: gtin is unavailable as the product made prior to compliance date; (b)(4).Initial reporter¿s phone number:(b)(6).The 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 improper maintenance which is user error/misuse/abuse.If additional information should become available, a supplemental medwatch report will be sent accordingly.

Event Description

It was reported from the (b)(6) that the motor device had an unspecified malfunction.During service and evaluation, it was observed that the device had damaged component - locking components and was completely worn out.It was further determined that the locking mechanism had a defect, motor had corrosion in it and the connector was out of specification.It was further noted that the device failed pre-test for cutter lock assessment, loctite and cable and safety.It was not reported whether the event occurred during surgery or whether there was patient involvement.It was not reported whether there were delays in the surgical procedure or if a spare device was available for use.It was not reported if there were any 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 MOTOR ASSEMBLY
• 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: 6069517
• MDR Text Key: 59018293
• Report Number: 1045834-2016-13092
• Device Sequence Number: 1
• Product Code: HBC
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K011444
• 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: 08/08/2016

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: EMAX2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2016
• Initial Date Manufacturer Received: 10/21/2016
• Initial Date FDA Received: 11/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2007
• 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