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

Catalog Number ND02-025/08 C

Device Problem Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 07/17/2018

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 that there was a potential sterility breach on the packaging of the device.It was also reported that it was noticed prior to the procedure.It was further reported that there was no delay or adverse consequences as a result of this event.

Manufacturer Narrative

The reported product involved with this event was returned for evaluation.On receipt of the product the product blister pack was observed to be open.The packaging development engineer concluded that the root cause for the open pack was undetermined.A device history record (dhr) review and retained sample testing of the packaging of this lot number was performed and all manufacturing specifications were met during the time of manufacture of this product.Nasopore product ifu contains the note; "do not use if the package is open or damaged.".

Event Description

It was reported that there was a potential sterility breach on the packaging of the device.It was also reported that it was noticed prior to the procedure.It was further reported that there was no delay or adverse consequences as a result of this event.

• Brand Name: NASOPORE FORTE 8CM
• Type of Device: SPLINT, INTRANASAL SEPTAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 7782542
• MDR Text Key: 117144605
• Report Number: 0001811755-2018-01582
• Device Sequence Number: 1
• Product Code: LYA
• Combination Product (y/n): N
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 10/19/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: ND02-025/08 C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2018
• Initial Date Manufacturer Received: 07/17/2018
• Initial Date FDA Received: 08/14/2018
• Supplement Dates Manufacturer Received: 10/10/2018
• Supplement Dates FDA Received: 10/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 1 DA