MAUDE Adverse Event Report: GYRUS ACMI, INC BURR, 6MM ROUND CUTTING 10-25 MM VAR EXPOSURE, USE WITH MDSSA AND MDASA; BUR, EAR, NOSE AND THROAT

Model Number MBUR6060FRCV

Device Problems Mechanical Problem (1384); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/21/2022

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: (concomitant devices)-= short, angled handpiece mdasa sn:(b)(4), motor handpiece egmdhp200 sn:(b)(4) and 5mm drill egmbur5060frcv.The subject device has not yet been received for evaluation.Device is being shipped to the legal manufacturer for investigation.To date, the device has not yet been received.Note: photo of the subject device was provided.Communication with the customer via service department, rep (tm), the following information conveyed: patient was under anesthesia at the time of the event.According to the customer, delay in the procedure due to the event caused no harm to patient (prolongation of the procedure not considered by the user as a serious deterioration of a person's health ("clinically relevant") to which this medical device may have contributed.Procedure involved was a mastoidectomy.According to the reporter, "the impact of the drill did not cause any injury to the patient".Investigation is ongoing.This report will be supplemented accordingly following investigation.

Event Description

As reported , the 6mm drill deflects in the handpiece during use.The drill jumps a few millimeters to the side.The pressure with the drill on the material to be drilled was only very low.This happened several times happened during the surgery.Excessive heating was not detected.The short, angled handpiece mdasa sn:(b)(4) was used with the motor handpiece egmdhp200 sn:(b)(4).The user then used the 5mm drill egmbur5060frcv in the same procedure and had no problems with it.There was no patient harm, no user injury reported due to the event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and the device evaluation.The device was returned to olympus for inspection, and the customer's complaint was not confirmed.The burr(mbur6060frcv) device was not returned in the original packaging.The burr appears to be unused with no presence of dents, markings or chips off the head of the burr.The locking grooves are in the correct placement on the burr and the tin coated tip is located correctly on the burr.Visually there is no failure present on the burr to cause the burr not to function as expected with the attachment and handpiece.There were no other abnormalities noted in the inspection.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the reported failure is a result of customer usage and assembly.The root cause has been determined to be customer assembly of the burr into the attachment and attachment to the handpiece.If the attachment is not locked into the handpiece properly then the burr (mbur6060frcv) cannot be inserted and locked into the attachment correctly.This will cause the burr(mbur6060frcv) to possibly dislodge out of the attachment and or "jump" while using the device.Proper assembly of the attachment is critical for the device to function properly with the handpiece.Olympus will continue to monitor field performance for this device.

• Brand Name: BURR, 6MM ROUND CUTTING 10-25 MM VAR EXPOSURE, USE WITH MDSSA AND MDASA
• Type of Device: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): GYRUS ACMI, INC; 2925 appling rd; bartlett TN 38133
• Manufacturer Contact: todd brill ; 2925 appling rd; bartlett, TN 38133 ; 5082077661
• MDR Report Key: 15443427
• MDR Text Key: 306417621
• Report Number: 1037007-2022-00017
• Device Sequence Number: 1
• Product Code: EQJ
• UDI-Device Identifier: 00821925036536
• UDI-Public: 00821925036536
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT-EQJ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/18/2023

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 Model Number: MBUR6060FRCV
• Device Lot Number: AV121761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/21/2022
• Initial Date FDA Received: 09/18/2022
• Supplement Dates Manufacturer Received: 12/19/2022
• Supplement Dates FDA Received: 01/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/27/2021
• 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
• Treatment: MDASA EGMDHP200 EGMBUR5060FRCV