MAUDE Adverse Event Report: GYRUS ACMI, INC BURR 3 MM, DIAMOND FINE, 10-25MM VAR EXPOSURE, USE WITH MDSLA AND MDALA

Model Number MBUR3075DVF

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/10/2019

Event Type  malfunction  

Manufacturer Narrative

The reported issue was found prior to use.The device has not yet been returned for evaluation, however a picture of the label and the device was provided by the user, confirming the product inside the package does not match the device package label.The investigation is ongoing.If additional information becomes available following device evaluation and investigation, a supplemental report will be filed.

Event Description

It was reported that an alternate burr was found inside the package, other than what was listed on the package label.The case was completed with an alternate size burr.

Manufacturer Narrative

This report has been updated in the following fields: d4, g4, g7, h2, h4 h6 and h10.Device history record review for the finished device was completed and no abnormalities in documentation or process was found.

• Brand Name: BURR 3 MM, DIAMOND FINE, 10-25MM VAR EXPOSURE, USE WITH MDSLA AND MDALA
• Type of Device: BURR
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 9284366
• MDR Text Key: 204525876
• Report Number: 3003790304-2019-00001
• 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
• Report Date: 02/20/2020

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 Expiration Date: 02/24/2024
• Device Model Number: MBUR3075DVF
• Device Lot Number: ME843875
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/11/2019
• Initial Date FDA Received: 11/06/2019
• Supplement Dates Manufacturer Received: 01/06/2020
• Supplement Dates FDA Received: 02/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1