MAUDE Adverse Event Report: GYRUS ACMI, INC BURR, 4MM, 70DEG, DIAMOND TAPER, 5/PK

Model Number BUR4070DT

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2020

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned (to (b)(6)).The initial evaluation noted the burr and approximately one to two inches of the distal portion was broken and detached.The axis inside the sheath of the bar was threaded.The likely cause was attributed to overlapping of the following: temperature rise of the shaft due to continuous rotation and the increase in load due to contact with dense bone/ foreign body.The investigation is ongoing; therefore, the root cause of the reported malfunction cannot be determined at this time.However, if additional information becomes available, this report will be supplemented accordingly.

Event Description

About 40 minutes an endoscopic sinus surgery, the diamond taper burr (70 degree, 4mm) reportedly stopped rotating.The surgeon then removed the burr from the patient, and confirmed that it was broken.The broken fragments were retrieved from the patient.The timing of the break was unknown.The burr was replaced and the intended procedure was completed.No patient impact or health hazards was reported.

Manufacturer Narrative

This supplemental report was submitted to provide additional information from the legal manufacturer for mdr# 1037007-2020-00103.As part of the investigation, olympus followed up with the user facility to obtain additional information but with no results the physical evaluation of the device discovered that since the shaft is threaded, it is possible that the shaft was damaged due to the combination of the rise of temperature due to continuous rotation and the load rise due to contact with hard bone and tissue.This will cause breakage and overheating of the device.The original equipment manufacturer (oem) can not performed a device history record review because a serial/lot number was not provided.The oem completed the investigation and determined that the likely cause of the reported event has been determined to be customer usage for a prolonged time.If the lot number is provided at a later date, a dhr review will occur to confirm that olympus manufactured the device within specification.Olympus will continue to monitor the field performance of this device.

• Brand Name: BURR, 4MM, 70DEG, DIAMOND TAPER, 5/PK
• Type of Device: BURR, 4MM, 70DEG, DIAMOND TAPER
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 11102167
• MDR Text Key: 228350150
• Report Number: 1037007-2020-00103
• Device Sequence Number: 1
• Product Code: EQJ
• UDI-Device Identifier: 00821925040595
• UDI-Public: 00821925040595
• 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
• Report Date: 01/27/2021

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: BUR4070DT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/02/2020
• Initial Date FDA Received: 12/31/2020
• Supplement Dates Manufacturer Received: 01/21/2021
• Supplement Dates FDA Received: 01/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1