MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC 11.0 CM LONG ATTACHMENT; MOTOR, DRILL, ELECTRIC - ATTACHMENT

Model Number LONG

Device Problems Difficult to Remove (1528); Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/02/2018

Event Type  malfunction  

Manufacturer Narrative

The serial/lot number was unknown; therefore, date of manufacture was unknown and (b)(4).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

This report 2 of 3 for the same event.It was reported that during an unspecified surgical procedure, it was observed that the motor device was very loud during bone removal of the femur.According to the report, the device was being used with an attachment device and a burr device.It was further reported that the noise was believed to be caused by a faulty attachment device.Subsequently, it was reported that the system displayed an error of the handpiece or drill communication error that the device had to re-calibrated and home.It was reported that the burring was quieter after that.However, once completed, it was reported that the drill was difficult to remove and the burr device was difficult to remove from the attachment device.It was reported that there were no delays in the surgical procedure and a spare device was available for use.There was patient involvement.There were no 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.

• Brand Name: 11.0 CM LONG 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: 7395196
• MDR Text Key: 104543560
• Report Number: 1045834-2018-50697
• Device Sequence Number: 1
• Product Code: HBC
• UDI-Device Identifier: 00845384003571
• UDI-Public: (01)00845384003571
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011444
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LONG
• Device Catalogue Number: LONG
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/13/2018
• 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