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

Catalog Number	5400010008
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available for return.A follow up report will be filed once the quality investigation is complete.
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: SPLINT, INTRANASAL SEPTAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 7619035
• Report Number: 0001811755-2018-01082
• Device Sequence Number: 1694614
• Product Code: LYA
• UDI-Device Identifier: 37613154340805
• UDI-Public: 37613154340805
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K052099
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 5400010008
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/24/2018
• Supplement Date Received by Manufacturer: 08/09/2018
• Initial Report FDA Received Date: 06/20/2018
• Supplement Report FDA Received Date: 08/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1