MAUDE Adverse Event Report: GYRUS ACMI, INC BURR, 1 MM, DIAMOND FINE; DIAMOND ENT BUR, SINGLE-USE

Model Number MBUR1060DVF

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/17/2018

Event Type  malfunction  

Manufacturer Narrative

The reported burr has not been returned to olympus for evaluation.The cause of the reported event cannot be confirmed.As a preventive measure, the owner¿s manual for the diego elite drill system contains warnings and cautions to avoid overheating and device damage: ¿avoid unnecessary and prolonged activation.This may result in excessive heating to the instrument, which could damage adjacent structures if brought into contact inadvertently or could damage the instrument tip and or the suction irrigation instrument.¿ ¿do not advance or extend the device abruptly.¿ and in general before each procedure, the owner¿s manual requires inspection of drill system components for damage or missing elements.To mitigate against device deterioration, the owner's manual also requires an annual safety check of the drill system by olympus authorized personnel.

Event Description

On december 17, 2018, olympus was informed that during the middle of a radical mastoidectomy cortical bone harvesting procedure with irrigation, the doctor observed the 1mm diamond variable fine burr broke off.No device fragment was retained in the patient¿s ear as the broken fragment was suctioned immediately.The intended procedure was completed using a 3mm cutting burr without issue.There was no patient injury reported.The physician has reportedly carried out this technique successfully for many years using their existing gyrus diego system.

Manufacturer Narrative

The concomitant devices used during the procedure did not have any issues.There was also no report of unusual behaviors prior to the burr breaking.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information regarding dhr review performed and device evaluation results.Please see the updates in sections: d10, g4, g7, h2, h3, h6 and h10.The service center was reviewed the returned complaint sample and confirmed the reported observation.The reason for the failure could not be definitively identified.As stated in the complaint, the area adjacent to the burr tip was blackened and presumed to be the result of the heat generated from cutting the bone without the use of irrigation which provides cooling.High heat may also be the result of applying a large amount of force during the cutting process.The area below the burr tip (the neck) was smaller in diameter than the burr tip and therefore would be the area most likely to break if the application force were too large.Also, the dhr was reviewed and the review found no related manufacturing anomalies at the time of product releases.

• Brand Name: BURR, 1 MM, DIAMOND FINE
• Type of Device: DIAMOND ENT BUR, SINGLE-USE
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 8238574
• MDR Text Key: 133084025
• Report Number: 2951238-2019-00355
• Device Sequence Number: 1
• Product Code: EQJ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT-EQJ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 08/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MBUR1060DVF
• Device Lot Number: HSD959165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONSOLE: UNKNOWN, S/N (B)(4).; HIGH SPEED DRILL KIT: DK0967