MAUDE Adverse Event Report: GYRUS ACMI, INC BURR, 4MM ROUND CUTTING 10-25 MM VAR EXPOSURE, USE WITH MDSSA AND MDASA

Model Number MBUR4060FRCV

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Date 03/01/2020

Event Type  malfunction  

Manufacturer Narrative

The devices were not returned for evaluation.The cause of the reported event cannot be determined at this time.

Event Description

The service center was informed that during preparation to use, it was noted that the labeling on the device packaging did not match the product inside.The packaging was not bent, dented or torn.It was reported that the customer ordered mastoid cutting burrs but received diamond burrs.There was no patient involvement and therefore no patient injury was reported.This is 5 of 7 reports.

Manufacturer Narrative

Dhr review was performed.Dhr for the finished device was reviewed and no abnormalities in documentation or process was found.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information received.Please see the updates in sections: g4, g7, h2 and h10.Upon further review, this is not a reportable malfunction.Per the legal manufacturer, there is no potential for this issue to cause or contribute to death or serious injury if the malfunction were to recur.

• Brand Name: BURR, 4MM ROUND CUTTING 10-25 MM VAR EXPOSURE, USE WITH MDSSA AND MDASA
• Type of Device: BURR, 4MM ROUND CUTTING 10-25 MM
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 9885412
• MDR Text Key: 215374555
• Report Number: 2951238-2020-00389
• Device Sequence Number: 1
• Product Code: EQJ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 02/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MBUR4060FRCV
• Device Lot Number: AV866148
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1