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

Catalog Number EG1A

Device Problem Detachment Of Device Component (1104)

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

Event Type  malfunction  

Manufacturer Narrative

The actual device was returned for evaluation.Reliability engineering evaluated the device and the reported condition was confirmed.A visual and functional assessment was performed which found that the device failed the resistor verification and the console device was not detecting the handpiece connection when it was plugged into the console.During repair, it was observed that the connector shell was separated from the connector mount due to insufficient loctite.It was further determined that the handpiece failure was due to the plug connector subassembly being loose and stuck, causing misalignment with the connector shell, thereby when plugged into the console the electrical pins were in the wrong holes.That was the reason the console was unable to detect the handpiece connection.It was determined that the failure was caused by insufficient application of loctite.The assignable root cause was determined to be due to a manufacturing processing issue.This issue has been escalated to capa.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Event Description

It was reported that the end of the motor device had separated but not fallen off.During in-house engineering evaluation, it was observed that the connector shell was separated from the connector mount due to insufficient loctite.The event was not reported to have occurred during surgery.It was not reported if there were any delays in a surgical procedure or if a spare device was available.It was not reported if there were any injuries, medical intervention or prolonged hospitalization.The exact date of this 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: 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: 7625905
• MDR Text Key: 111903685
• Report Number: 1045834-2018-51152
• Device Sequence Number: 1
• Product Code: HBC
• UDI-Device Identifier: 845384017134
• UDI-Public: (01)845384017134(11)170803
• 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: 04/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2018
• 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: 05/18/2018
• Date Manufacturer Received: 06/15/2018
• Date Device Manufactured: 08/03/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1