MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS 12.4CM HEAVY DUTY LONG ATTCH; MOTOR, DRILL, ELECTRIC - ATTACHMENT

Catalog Number LONG-HD_LL

Device Problems Overheating of Device (1437); Device Operates Differently Than Expected (2913); Naturally Worn (2988)

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

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: (b)(4).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 that the device was running over the temperature specification (123 degrees, should be less than 118 degrees).It was also observed that the bearings were worn out.It was determined that the worn out bearings were causing the temperature issue.The assignable root cause was determined to be due to component damage from normal use and servicing over time.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Event Description

It was reported that the long attachment device was not working properly.During in-house engineering evaluation it was found that the device was running over the temperature specification, and the bearings were worn out.The event was not reported to have occurred during surgical procedure.It was not reported if there were any delays in a surgical procedure or if a spare device was available.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.The exact date of the event was unknown.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: 12.4CM HEAVY DUTY LONG ATTCH
• Type of Device: MOTOR, DRILL, ELECTRIC - ATTACHMENT
• 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: 5847133
• MDR Text Key: 52336818
• Report Number: 1045834-2016-12379
• Device Sequence Number: 1
• Product Code: HBC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011444
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/08/2016

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: LONG-HD_LL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2016
• Initial Date Manufacturer Received: 08/01/2016
• Initial Date FDA Received: 08/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2013
• 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