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

Catalog Number 5400010008

Device Problem Packaging Problem (3007)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/24/2018

Event Type  malfunction  

Manufacturer Narrative

The device is available for return.A follow up report will be filed once the quality investigation is complete.

Event Description

It was reported during a surgical procedure, that there was a potential sterility breach on the packaging.It was also reported that there was no delay as a result of this event.It was further reported that there were no adverse consequences and the procedure was completed successfully.

Manufacturer Narrative

The product and packaging was not returned for evaluation.The reported event, for packaging issue, was not confirmed as the product and packaging was not returned for evaluation.Without the product and packaging, the root cause cannot be determined.Device not available for return, no further information available.

Event Description

It was reported during a surgical procedure, that there was a potential sterility breach on the packaging.It was also reported that there was no delay as a result of this event.It was further reported that there were no adverse consequences and the procedure was completed successfully.

• Brand Name: NASOPORE STANDARD 8CM, 8/PK
• Type of Device: 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
• Manufacturer Contact: una barry ; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; 214532900
• MDR Report Key: 7619035
• MDR Text Key: 111652969
• Report Number: 0001811755-2018-01082
• Device Sequence Number: 1
• Product Code: LYA
• UDI-Device Identifier: 37613154340805
• UDI-Public: 37613154340805
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052099
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5400010008
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/09/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1