MAUDE Adverse Event Report: GYRUS ACMI, INC SMART STAPES PISTON .5 X 4.50 MM; POLYETHYLENE CRANIOFACIAL TISSUE RECONSTRUCTIVE MATERIAL

Model Number	70145923
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported to olympus the implant fell out of 'the window.' the patient went to his physician after having increased pressure when shoveling snow.The piston was displaced.It is unclear if the patient was harmed or injured by the displaced implant.The indication for the implant is unknown.The original implant date was (b)(6) 2021.It is unknown if there were any issues during implantation or if the implant was securely placed.There was no difficulty removing the implant.
Additional Manufacturer Narrative
The suspect device has not been returned to olympus for evaluation.The investigation is in process.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer¿s investigation and the results of the device history records (dhr) review.The olympus service center evaluated the returned device and identified the following: part was not returned in original packaging, the device was returned in closed specimen cup with solution.The device was noted for the nitinol wire and fluoroplastic anchor being in tacked.The loop on the nitinol wire was present but the wire shaft is bent.The wire shaft should be straight leading into the fluoroplastic.There is no color difference in material, the nitinol wire is grey in color and the fluoroplastic is white in color.The reported failure could have occurred when connecting the hook around the bone (incus) and securing the fluoroplastic end to the open window.The nitinol wire could have bent in the process.The dhr for this device were reviewed and all records indicated the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.A definitive root cause was not identified.Based on the available information, the legal manufacturer determined the probable cause of the failure is likely due to transportation or customer use.Per instructions for use: the shape-memory properties of the nitinol are designed to aid the surgeon in the crimping of the wire loops around the incus or malleus.In most cases, further crimping will not be necessary, however, the surgeon should always check the wire loops to determine if additional manual adjustment (tightening or loosening) of the crimp should be made.Olympus will continue to monitor field performance for this device.

• Brand Name: SMART STAPES PISTON .5 X 4.50 MM
• Common Device Name: POLYETHYLENE CRANIOFACIAL TISSUE RECONSTRUCTIVE MATERIAL
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• Manufacturer Contact: brian motter ; 2925 appling rd; bartlett, TN 38133 ; 4848965250
• MDR Report Key: 14575425
• Report Number: 1037007-2022-00008
• Device Sequence Number: 12290588
• Product Code: ETB
• UDI-Device Identifier: 00821925023697
• UDI-Public: 00821925023697
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K003214
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 70145923
• Device Lot Number: PR867175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2022
• Supplement Date Received by Manufacturer: 08/03/2022
• Initial Report FDA Received Date: 06/02/2022
• Supplement Report FDA Received Date: 08/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Male