MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC HIGH SPEED ELEC G1 HANDPIECE AIR COOLED; MOTOR, DRILL, ELECTRIC - HANDPIECE

Catalog Number EG1A

Device Problems Overheating of Device (1437); Naturally Worn (2988)

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

Event Date 03/13/2018

Event Type  malfunction  

Manufacturer Narrative

The actual device was returned for evaluation.Reliability engineering evaluated the device and determined that the motor device was making a rattling noise, the bearings within the burr-lock were worn out causing the rattling and overheating.The device also failed the temperature assessment pre-test.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to wear from normal use and servicing over time.If additional information should become available, a suplemental medwatch will be submitted accordingly.

Event Description

It was reported that the during pre-surgery, the motor device made a rattling noise.During in-house engineering evaluation, it was determined that the device over heated and the bearings were worn out.This event did not occur during surgery.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 will be submitted accordingly.

• Brand Name: HIGH SPEED ELEC G1 HANDPIECE AIR COOLED
• Type of Device: MOTOR, DRILL, ELECTRIC - HANDPIECE
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: kate karberg ; 4500 riverside drive; palm beach gardens, FL 33410 ; 5616271080
• MDR Report Key: 7568443
• MDR Text Key: 110035130
• Report Number: 1045834-2018-51055
• Device Sequence Number: 1
• Product Code: HBC
• UDI-Device Identifier: 845384017134
• UDI-Public: (01)845384017134(11)140826
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133604
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EG1A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2018
• Date Manufacturer Received: 05/18/2018
• Date Device Manufactured: 08/26/2014
• 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