MAUDE Adverse Event Report: GYRUS ACMI, INC. GOLDENBERG MAL PORP, HA/PP; REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL

Model Number	140964
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, the implant broke while trying to implant in the middle ear.The event occurred during a tympanoplasty with ossicular chain reconstruction procedure.The intended procedure was completed with a similar device with no delay.There were no reports of patient harm.
Additional Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Correction to g2 of the initial report."company representative" should have also been selected as a report source.This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The device was returned and based on the results of the investigation, olympus confirmed the device was broken between the foot and the shaft.The most probable root cause for this malfunction is adverse event related to procedure.However, a definitive root cause cannot be determined.The following is included in the device instructions for use (ifu): as all prothesis are inherently delicate and some materials such as hydroxyapatite, are brittle in nature, careful handling is essential to prevent damage during manipulation, trimming or sizing and implantation.Olympus will continue to monitor the field performance of this device.

• Brand Name: GOLDENBERG MAL PORP, HA/PP
• Common Device Name: REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL
• Manufacturer (Section D): GYRUS ACMI, INC.; 2925 appling rd; bartlett TN 38133
• Manufacturer (Section G): GYRUS ACMI, INC.; 2925 appling rd; bartlett TN 38133
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 20501575
• Report Number: 1037007-2024-00010
• Device Sequence Number: 18243266
• Product Code: ETA
• UDI-Device Identifier: 00821925017429
• UDI-Public: 00821925017429
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K864443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2024

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: Health Professional
• Device Model Number: 140964
• Device Lot Number: AV191840
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2024
• Supplement Date Received by Manufacturer: 11/12/2024
• Initial Report FDA Received Date: 10/22/2024
• Supplement Report FDA Received Date: 11/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown