MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP HEMOPORE 8CM, 8/PK; SPLINT, INTRANASAL SEPTAL

Catalog Number	5400020208
Medical Device Problem Codes	Material Too Rigid or Stiff (1544); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	03/17/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.
Event or Problem Description
It was reported that one week post functional endoscopic sinus surgical procedure, two patients presented with an inflammatory response.This report addresses one of the patients.No further information was provided.
Additional Manufacturer Narrative
Correction; b1; adverse event only.No reported information of a product malfunction.H6: the quality investigation is complete.H3 other text : product used in patient.
Event or Problem Description
It was reported that one week post functional endoscopic sinus surgical procedure, two patients presented with an inflammatory response.This report addresses one of the patients.No further information was provided.

• Brand Name: HEMOPORE 8CM, 8/PK
• Common Device Name: SPLINT, INTRANASAL SEPTAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• 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: 16745035
• Report Number: 3015967359-2023-00739
• Device Sequence Number: 15064372
• Product Code: LYA
• UDI-Device Identifier: 37613327117234
• UDI-Public: 37613327117234
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2024

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 5400020208
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/17/2023
• Supplement Date Received by Manufacturer: 02/19/2024
• Initial Report FDA Received Date: 04/14/2023
• Supplement Report FDA Received Date: 04/05/2024
• 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: Required Intervention
• Patient Sex: Unknown