MAUDE Adverse Event Report: GYRUS ACMI, INC. SMART STAPES PISTON .4 X 5.25 MM; PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT

Model Number	70142168
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare professional from a user facility reported that during implantation of the prosthesis, the nitinol plastic separated from the wire.A new prosthesis had to be opened.There was no patient injury or adverse event reported to olympus.
Additional Manufacturer Narrative
This mdr is being submitted as part of a retrospective review and remediation effort based on enhancements made to the company¿s mdr and complaint handling processes.Capas have been opened to manage the actions that are being taken to remediate this issue and ensure any required mdr reporting is completed.The device was not returned to olympus for evaluation to confirm the customer's complaint.Due to the customer discarding the device, a physical inspection could not be completed.As this device was inspected per dhr review, evaluation of the device passed all inspections, it is unlikely the device left the facility damaged.Therefore, the reported failure is likely due to customer misuse.A review of the device history record found no deviations that could have caused or contributed to the reported issue.A definitive root cause cannot be identified.Olympus will continue to monitor the field performance of this device.

• Brand Name: SMART STAPES PISTON .4 X 5.25 MM
• Common Device Name: PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT
• Manufacturer (Section D): GYRUS ACMI, INC.; 2925 appling rd; bartlett TN 38133
• Manufacturer (Section G): GYRUS ACMI INC.; 800 west park drive; westborough MA 01581
• Manufacturer Contact: todd brill ; 2925 appling rd; bartlett, TN 38133 ; 5082077661
• MDR Report Key: 15123185
• Report Number: 1037007-2022-00012
• Device Sequence Number: 7381954
• Product Code: ETB
• UDI-Device Identifier: 00821925021594
• UDI-Public: 00821925021594
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K003214
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/28/2022

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: 70142168
• Device Lot Number: PR913965
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2021
• Initial Report FDA Received Date: 07/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2020
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown