MAUDE Adverse Event Report: GN HEARING A/S GN RESOUND; HEARING AID, AIR-CONDUCTION WITH WIRELESS TECHNOLOGY

Model Number	21385600
Medical Device Problem Codes	Product Quality Problem (1506); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Estimated date of incident (b)(6) 2024 it was reported that a hearing aid receiver broke.It is unknown whether it broke inside or outside the ear.No harm to the user has been reported.No further follow up is available or expected.
Additional Manufacturer Narrative
Manufacturer's ref# (b)(4).Manufacturer's investigation: technical investigation concluded: a dhr review have been completed.No deviation or changes were found during manufacturing of the device.Clinical conclusion: it has been reported that a receiver broke at the seam where the colored part meets the grey part.It is unknown if the receiver broke while in the ear, or outside the ear.There is no mention of whether the receiver was stuck in the ear, and no mention of any harm to the user following the break of the receiver.Initial screening question asking if there was any harm has been answered with "no".Despite attempts it has not been possible to gather further information.Clinical conclusion on the event is that the broken receiver most likely has not caused any harm to the user.The clinical evaluation for the device family does evaluate receivers coming loose in the ear canal.This is identified in the risk analysis and mitigated through device design by ensuring a sufficient pull force.The user guide states to contact the hcp if a foreign object or wax is located in the ear canal to reduce the potential risk of harm as far as possible.There are no new clinical aspects (e.G.Unforeseen use or clinical conditions) discovered from this event.Therefore, it is concluded that the current clinical evaluation and risk/benefit conclusions herein are sufficient.Risk assessment: risk related to mechanical damage are generally known mitigated and communicated to the user.All resulting actions are contained within the capa which includes an assessment of risks and associated updates.Trended case device investigation findings: adhesive failure mode is observed on failed devices.Adhesive to adherent interfaces detached from each other.Adhesive failure modes occur due to several factors such as inappropriate adhesive selection, pure surface preparation, and exposure to environmental factors.Assembly lines do not overlap totally but leave open gaps, creating pockets for ingress and retention of adhesion degrading media.Used adhesive technical sheet suggests avoiding adhesive usage in chlorinated environments - we have body contacts.Manufacturer's investigation is final.This is a combined (initial and final) report.

• Brand Name: GN RESOUND
• Common Device Name: HEARING AID, AIR-CONDUCTION WITH WIRELESS TECHNOLOGY
• Manufacturer (Section D): GN HEARING A/S; lautrupbjerg 7; ballerup, 2750 ; DA 2750
• Manufacturer Contact: akanksha roy ; lautrupbjerg 7; ballerup, 2750 ; DA 2750
• MDR Report Key: 20531432
• Report Number: 3005650109-2024-00094
• Device Sequence Number: 6773028
• Product Code: OSM
• UDI-Device Identifier: 05708296219445
• UDI-Public: 05708296219445
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/25/2024

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
• Operator of Device: Lay User/Patient
• Device Model Number: 21385600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2024
• Initial Report FDA Received Date: 10/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/10/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown