MAUDE Adverse Event Report: GYRUS ACMI, INC BURR, 3MM, 70DEG, DIAMOND BULLET, 5/PK; EAR, NOSE, AND THROAT BUR

Model Number BUR3070DB

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/01/2021

Event Type  malfunction  

Manufacturer Narrative

The subject device referenced in this report was not returned for evaluation, therefore the device evaluation could not be completed at this time.The exact cause of the reported event could not be conclusively determined at this time.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

The user facility reported that during a functional endoscopic sinus surgery (fess), the device did not work as intended.The burr had initially worked, then eventually stopped completely.A console and two (2) separate handpieces were used with the burr for testing, however the issue remained.The drill was taken from the handpiece and it was observed that part of the white piece of plastic in the drill where the drill is inserted into the handpiece was chipped up.The procedure was prolonged over an hour and was then aborted due to a lack of burrs.The patient had to be rescheduled for a new procedure.There was no patient harm reported.The device was inspected prior to the procedure and no damage or abnormalities were observed.The user facility later reported that the reason why the burrs broke was that they were used on a patient with an osteoma.The bone tissue was too hard for the burr to drill away.The rotation speed of the shaver became too small to handle this.The customer acknowledged that burrs were used in a procedure they are not intended to be used in.This complaint is related to patient identifiers; (b)(6) and (b)(6).

Manufacturer Narrative

This supplemental report is being submitted to provide additional information that was received from the user facility and the legal manufacturer¿s investigation.Per the customer, there were no comorbidities as the patient was a healthy young man.The cause of the surgery was due to a large osteoma that grew into the orbit and resulted in reduced mobility and double vision.Everything went as planned during the surgery except that the equipment did not work and they did not get the last part of the osteoma.The legal manufacturer performed an investigation.The dhr review could not be performed as no lot number was reported and there was no device return to inspect for a lot number.If the lot number becomes available at a later date, the dhr shall be reviewed.The definitive root cause of the burr tightness could not be confirmed as the device was not returned.However, per the torque verification procedure for diego elite burrs, a burr undergoes a test where the burr is smoothly rotated until a click is heard, or induction weld fails.As a result, it is unlikely that the burr would be shipped with issues regarding the burr feeling tight or not spinning.This suggests that the damages that may have been incurred on the burr were a result of transportation or use.

• Brand Name: BURR, 3MM, 70DEG, DIAMOND BULLET, 5/PK
• Type of Device: EAR, NOSE, AND THROAT BUR
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 11344179
• MDR Text Key: 256691304
• Report Number: 1037007-2021-00017
• Device Sequence Number: 1
• Product Code: EQJ
• UDI-Device Identifier: 00821925038257
• UDI-Public: 00821925038257
• 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: 03/12/2021

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: BUR3070DB
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/02/2021
• Initial Date FDA Received: 02/18/2021
• Supplement Dates Manufacturer Received: 02/22/2021
• Supplement Dates FDA Received: 03/12/2021
• Patient Sequence Number: 1
• Treatment: MDCONS100, MULTIDEBRIDER POWER CONSOLE.; MDHP100S, MULTIDEBRIDER HANDPIECE, STRAIGHT.; MDHP100S, MULTIDEBRIDER HANDPIECE, STRAIGHT.