MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS 5CM HEAVY DUTY SHORT ATTACHMENT; MOTOR, DRILL, ELECTRIC - ATTACHMENT

Catalog Number SHORT-HD

Device Problems Overheating of Device (1437); Naturally Worn (2988); Noise, Audible (3273)

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

Event Date 11/08/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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

This is report 1 of 2 for the same event: it was reported that during a hip revision surgical procedure, it was discovered that the attachment device and motor device heated up while being used together.It was further reported that the distal tip of the attachment device was worn down and it made a rattling noise.The reporter stated that the motor device ran extremely hot due to the strenuous load from the surgeon using a drill bit device, which was too long for use with the attachment device.It was further reported that a case tray was set up with heavy duty devices ¿xl-hd¿ and ¿long-hd¿ as an option to perform the trough cut for the bone-to-cement interface disruption needed for the extended trochanteric osteotomy (eto).However, these devices were not used.According to the reporter, the surgeon preferred to continue using the attachment device even after it began running extremely hot which caused the motor device to become extremely hot.It was reported that the extreme heat while uncomfortable did not cause any injuries.It was reported that the surgeon did not want to change the handpiece device for a spare device since the handpiece device did not reach the overheating-shutdown temperature.It was reported that the surgery was successfully completed.According to the reporter, after the devices were cleaned and then tested, the motor device worked fine and was placed back into circulation and had been used since without any issues.It was reported that the heavy side load strain and drill being too long clearly wore down the distal tip and caused the rattling noise.There was no delay to the surgical procedure and spare devices were available for use.There was patient involvement reported.There were no 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 determined that the bearings were worn out/damaged, loose and no longer in axial alignment creating a situation where the device overheated.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to wear from normal use and servicing over time.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 5CM HEAVY DUTY SHORT ATTACHMENT
• Type of Device: MOTOR, DRILL, ELECTRIC - ATTACHMENT
• 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: 6145049
• MDR Text Key: 61865183
• Report Number: 1045834-2016-13359
• Device Sequence Number: 1
• Product Code: HBC
• 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,Followup
• Report Date: 11/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SHORT-HD
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/16/2016
• Initial Date FDA Received: 12/05/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2016
• 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
• Treatment: DRILL BIT DEVICE; MOTOR DEVICE