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

Catalog Number EG1A_LL

Device Problems Break (1069); Detachment Of Device Component (1104); Device Contamination with Chemical or Other Material (2944); Scratched Material (3020)

Patient Problem No Patient Involvement (2645)

Event Date 02/11/2016

Event Type  malfunction  

Manufacturer Narrative

The actual device was returned for evaluation.Reliability engineering evaluated the device and observed that the that handpiece failed temperature assessment test.It was further reported that the burr lock mechanism assembly was disassembled and buildup of medical debris and residue was observed.It was also noted that the distal bearings had debris, spindle has scars and the housing had scars.Therefore, the reported condition was confirmed.The assignable root cause determined to be due to be improper cleaning at the customer site.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

This is report 1 of 2 for the same event.It was reported that during pre-surgery setup, it was observed that the shaft of a cutter device broke off inside the handpiece device.During an in-house engineering evaluation it was observed that handpiece failed temperature assessment test.It was further reported that the burr lock mechanism assembly was disassembled and buildup of medical debris and residue were observed.It was also noted that the distal bearings had debris, spindle has scars and the housing had scars.There were no delays in the surgical procedure and spare devices were available for use.There was no patient involvement.There were no patient or user injuries reported.It was reported there was no 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: 5531303
• MDR Text Key: 41681855
• Report Number: 1045834-2016-10942
• 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
• Report Date: 02/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EG1A_LL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2016
• Date Manufacturer Received: 03/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/23/2015
• 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