MAUDE Adverse Event Report: MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM; SURGICAL TOOLS

Model Number DIAMOND BUR 0.6MM

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Foreign Body In Patient (2687); Insufficient Information (4580)

Event Date 11/30/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, during a cochlear implantation surgery, a 0,6mm diamond burr broke and a piece of the device fell inside the cochlea.The piece was successfully removed, however, the cochlea got damaged during the procedure and therefore it was decided to not implant on this side.No confirmation regarding any possible damage of the cochlea during the surgery procedure has been received yet.

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.When available, a device failure analysis will be submitted as a follow up report.

Manufacturer Narrative

Conclusions: according to the information received from the field, during a difficult ci implantation surgery, a 0,6mm diamond burr broke.Based on the available information, a possible cause might be excessive wear of the re-used bur, but the exact root cause for the broken bur cannot be determined at this point.No device has been returned for device investigation, and it was not possible to gather further information at the involved clinics.Furthermore, the broken piece of burr was successfully removed, however, the cochlea got damaged during the procedure and therefore it was decided to not implant on the concerned side.

Event Description

On (b)(6) 2022, during a difficult ci implantation surgery (see related complaint (b)(4)) a 0,6mm diamond burr broke and a piece of the device fell inside the cochlea.The piece was successfully removed, however, the cochlea got damaged during the procedure and therefore it was decided to not implant on this side.In addition, as per related complaint information, during the initial insertion attempt, the implant could not be inserted because of an unexpectedly ossified cochlea.Only 2 electrodes could be inserted and, due to the ossification of the cochlea, and it was necessary to find another angle to open up the cochlea, therefore a cochleostomy was performed by using the 0,6mm diamond burr, which broke while drilling.The surgery has been significatively prolonged due to the reported misadventure.

• Brand Name: MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
• Type of Device: SURGICAL TOOLS
• Manufacturer (Section D): MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH; innsbruck ; AU
• Manufacturer Contact: laura simonotti ; fuerstenweg 77a; innsbruck 6020 ; AU 6020 ; 57788
• MDR Report Key: 15994173
• MDR Text Key: 305811809
• Report Number: 9710014-2022-00965
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: ID
• PMA/PMN Number: P000025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DIAMOND BUR 0.6MM
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/05/2022
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 33 MO