MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC 11 CM MEDIUM,QD ANGLE ATTACHMENT; MOTOR, DRILL, ELECTRIC - ATTACHMENT

Catalog Number QD11-G1

Device Problems Difficult to Remove (1528); Device Operates Differently Than Expected (2913)

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

Event Date 02/21/2018

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.The actual device has been returned and is currently pending evaluation.Once the evaluation of the device has been completed, a supplemental medwatch report will be sent accordingly.

Event Description

This is report 2 of 2 for the same event.It was reported that during an unspecified surgical procedure of the spine, it was observed that the handpiece device displayed a c-2 error code and an attachment device became stuck to the handpiece device.It was reported that there was no delay in the procedure as identical spare devices were available for use.The reporter stated that the eg1 system went through troubleshooting by resetting the system.It was reported that the system reset cleared the code and the procedure continued.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 will be submitted accordingly.

Manufacturer Narrative

Device was used for treatment, not diagnosis.The actual device was returned for evaluation.Reliability engineering evaluated the device and determined that the reported condition that the device was stuck in the handpiece was confirmed.An assessment was performed and it was observed that the attachment device would not secure the cutter.During repair it was observed that the springs in the burr lock had came out of position and were not pushing on the lock tabs to secure the cutters.It was determined that this condition was due to running the device without the cutter installed, which is failure to follow the direction for use (dfu).The assignable root cause was determined to be component damage caused by user error.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: 11 CM MEDIUM,QD ANGLE ATTACHMENT
• Type of Device: MOTOR, DRILL, ELECTRIC - ATTACHMENT
• 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: rodney crain ; 4500 riverside drive; palm beach gardens, FL 33410 ; 5616271080
• MDR Report Key: 7349424
• MDR Text Key: 102947051
• Report Number: 1045834-2018-50548
• Device Sequence Number: 1
• Product Code: HBC
• UDI-Device Identifier: 845384016380
• UDI-Public: (01)845384016380(11)150528
• 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,Followup
• Report Date: 02/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: QD11-G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/28/2015
• 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