MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO NASOPORE FD 8CM, 8/PK; SPLINT, INTRANASAL SEPTAL

Catalog Number	5400020108
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Wound Infection (2447)
Date of Event	01/31/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6: a follow up report will be filed once the quality investigation is complete.H3 other text : product used in patient.
Event or Problem Description
It was reported post operatively that a surgeon stated that the product caused infection.It was also reported there were no delays as a result of this event.It was further reported that the procedure was completed successfully.No further information was provided.
Event or Problem Description
It was reported post operatively that a surgeon stated that the product caused infection.It was also reported there were no delays as a result of this event.It was further reported that the procedure was completed successfully.No further information was provided.
Additional Manufacturer Narrative
H6: the quality investigation is complete.

• Brand Name: NASOPORE FD 8CM, 8/PK
• Common Device Name: SPLINT, INTRANASAL SEPTAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer (Section G): STRYKER INSTRUMENTS-IRELAND; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA
• Manufacturer Contact: colette chung ; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA ; 214532900
• MDR Report Key: 18985579
• Report Number: 0001811755-2024-00009
• Device Sequence Number: 11480205
• Product Code: LYA
• UDI-Device Identifier: 07613327117226
• UDI-Public: (01)07613327117226(17)240927(10)2023040317
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2024

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 Catalogue Number: 5400020108
• Device Lot Number: 2023040317
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/18/2024
• Supplement Date Received by Manufacturer: 09/18/2024
• Initial Report FDA Received Date: 03/27/2024
• Supplement Report FDA Received Date: 10/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Required Intervention
• Patient Sex: Unknown