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 12/05/2022

Event Type  Injury  

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.

Event Description

On (b)(6) 2022, while using the diamond burr 0.6mm for cochleostomy, the device broke and got stuck inside the bone.After trying for 2 hours to get out a piece of burr which was stuck in the bone, the surgeon decided to close the surgery.The user was not implanted due to the circumstances.Further surgery has been scheduled.

Manufacturer Narrative

Conclusions: according to the information received from the field, during a ci implantation surgery a 0,6mm diamond bur 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 tool 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, following removal of the broken piece of bur, the cochlea got damaged during the procedure and therefore it was decided to implant the contralateral side.

Event Description

On (b)(6) 2022, while using the diamond burr 0,6mm for cochleostomy, the device broke and got stuck inside the bone.After trying for 2 hours to get out the broken piece of bur which was stuck in the bone, the surgeon decided to conclude the surgery.The patient was not implanted because of these circumstances, and was hospitalized for 6 days as the doctor wanted to observe any side effect due to the administration of additional antibiotics.Further surgery took place on (b)(6) 2022.The bur was extracted, and the user was implanted on the contra-lateral side.Reportedly, it was decided to implant the user on the contralateral side because the cochlea got damaged by the presence or the extraction of the broken bur.

• 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: 15994175
• MDR Text Key: 305586208
• Report Number: 9710014-2022-00966
• 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
• Device Lot Number: LOT 0611B
• 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: 7 YR
• Patient Sex: Male