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

Catalog Number EG1A

Device Problems Degraded (1153); Failure to Power Up (1476)

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

Event Date 02/15/2016

Event Type  malfunction  

Manufacturer Narrative

The actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that during the approaching segment of an acoustic neuroma surgical procedure, it was observed that the motor device hose that connected to the lima connector came apart exposing the wires on the hose.The hose was carefully placed back inside the connector and the hand piece did not heat up.The case was successfully completed without any delays.It was unknown if a spare device was available for use.There was 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 report will be submitted accordingly.

Manufacturer Narrative

The actual device was returned for evaluation.Reliability engineering evaluated the device and observed that the nut air hose connector had detached from mount air hose connector.Therefore, the reported condition was confirmed.It was determined that the separation of the components joint was determined to be due to lack of loctite thread locker adhesion to the threaded connectors.It was determined that the original assembly adhesive had not been properly applied during the manufacturing process.The assignable root cause was determined to be due to improper assembly during manufacturing.The event has been escalated to capa.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: G1 HIGH SPEED ELECTRIC HANDPIECE, AIR CO
• 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: 5484059
• MDR Text Key: 40039820
• Report Number: 1045834-2016-10649
• Device Sequence Number: 1
• Product Code: HBC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK133604
• 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,Followup
• Report Date: 02/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2016
• 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: 02/25/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/05/2015
• 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