MAUDE Adverse Event Report: GYRUS ACMI, INC BIVALVE SPLINT LARGE THICK,.50MM,UHMWPE (12PK); SPLINT, INTRANASAL SEPTAL

Model Number	890919
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	01/23/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported the lack of flexibility of the splint which caused a perforation of the nasal septum with necrosis of the cartilage.No additional information has been provided to date.
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 manufacturing date, h4 updated.
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.New information added to h6, h10.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 customer use.No causal relationship was identified between the event and device.

• Brand Name: BIVALVE SPLINT LARGE THICK,.50MM,UHMWPE (12PK)
• Common Device Name: SPLINT, INTRANASAL SEPTAL
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• Manufacturer Contact: kenneth pittman ; 2925 appling rd; bartlett, TN 38133 ; 9013785969
• MDR Report Key: 13581159
• Report Number: 1037007-2022-00005
• Device Sequence Number: 5817608
• Product Code: LYA
• UDI-Device Identifier: 00821925040311
• UDI-Public: 00821925040311
• Combination Product (Y/N): N
• Initial Reporter Country: LU
• PMA/510(K) Number: EXEMPT
• 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,Followup
• Report Date (Section B): 04/13/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: 890919
• Device Lot Number: PR111667
• Was Device Available for Evaluation?: No
• 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: 01/24/2022
• Supplement Date Received by Manufacturer: 04/13/2022; 04/13/2022
• Initial Report FDA Received Date: 02/22/2022
• Supplement Report FDA Received Date: 04/13/2022; 04/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2021
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown