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

Catalog Number EG1A

Device Problems Metal Shedding Debris (1804); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 06/15/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The actual device was returned for evaluation.Reliability engineering evaluated the device and observed that there was a metal particle at the burr lock assembly.The burr lock mechanism assembly was disassembled and the 2 springs (44-2442) for the lock tabs (44-2790) had failed and were not pushing on the lock tabs to secure cutter devices.It was observed that one of the springs was out of place and disintegrated.It was further observed that the other spring was out of place and was completely gone.Therefore, the reported condition was confirmed.It was determined that the springs came out of place as a result of the handpiece being run without a cutter device.The assignable root cause was determined to be due to user misuse/abuse.If information is obtained that was not available, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that during a sterilization process, it was observed that the motor device had metal pieces coming out of the cord and the device did not run well.There was no patient involvement reported.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: HIGH SPEED ELEC G1 HANDPIECE AIR COOLED
• 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: 5890385
• MDR Text Key: 53468879
• Report Number: 1045834-2016-12485
• Device Sequence Number: 1
• Product Code: HBC
• 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: 06/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EG1A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2016
• Date Manufacturer Received: 06/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2014
• 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