MAUDE Adverse Event Report: GYRUS ACMI, INC BURR, 3MM ROUND CUTTING 10-25 MM VAR EXPOSURE, USE WITH MDSSA AND MDASA

Model Number MBUR3060FRCV

Device Problem Unintended System Motion (1430)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/06/2017

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to olympus for evaluation.The cause of the reported event cannot be determined at this time.The instruction manual provides several warnings to prevent procedure complications.¿ensure burr is securely locked into place before powering on.Always use the device as outlined in this instruction manual.Improper use will not only impede functions and prevent optimum performance, but may cause equipment damage and / or complications.Before each use, always inspect the equipment as outlined in this instruction manual.Inspect the drill handpiece for damage or missing parts prior to and after each use.If the drill handpiece or cable is damaged, do not use it.Return it to an authorized repair facility.Verify functionality prior to each use¿.

Event Description

Olympus was informed that during a mastoid with ossicular chain reconstruction procedure, the surgeon reported that five burrs were jumping around and the drill had a lot of chatter.There was no bleeding reported.There was no longer stay or additional procedures required.The procedure was prolonged by 2 hours due to the issues with all the burrs.The procedure was completed.There was no patient injury reported.This report 4 of 5.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information provided from the original equipment manufacturer (oem).The oem reported that the burr chatter and vibration is a known phenomenon that is associated with the high speed drill.The burr chatter and vibration is also present in all similar devices.The potential effect of the burr chatter and vibration has been determined to be surgeon dissatisfaction, a delayed procedure and the hand-piece not performing as intended.The cutting performance is highly subjective and technique dependent making it very difficult to predict and test for all usage scenarios and techniques.It has been determined that the perceived reduced cutting performance does not represent a danger to the patient or user.The oem performed a review of the dhr for the subject device and lot number and found no anomalies noted during the manufacturing of this device.In addition, a corrective action has been initiated to further investigate burr chatter associated with the diego elite high speed drill and to determine an appropriate action plan.However, the instruction for use has been updated to include the following warning: ¿warning! there is a potential for the burr to "chatter" or "jump" during the drilling of bone when using a burr of 5 mm or greater, particularly when extended to longer lengths (p3 or p4).This phenomenon can be unpredictable and can damage adjacent anatomical structures.Therefore, the medical practitioner should exercise caution in using the larger diameter burr products, particularly if in close proximity to sensitive or vital anatomical structures.Drilling in those areas can be completed using a less aggressive diamond cutting burr.¿.

• Brand Name: BURR, 3MM ROUND CUTTING 10-25 MM VAR EXPOSURE, USE WITH MDSSA AND MDASA
• Type of Device: BURR, 3MM ROUND CUTTING
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• Manufacturer Contact: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 408935-512
• MDR Report Key: 6760803
• MDR Text Key: 81674457
• Report Number: 2951238-2017-00502
• Device Sequence Number: 1
• Product Code: EQJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• 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: 12/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MBUR3060FRCV
• Device Catalogue Number: MBUR3060FRCV
• Device Lot Number: HSD959146
• Other Device ID Number: UDI
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1