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

Catalog Number	5400010008
Medical Device Problem Code	Material Disintegration (1177)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Product used by patient, not available for return.
Event or Problem Description
It was reported that post operatively that the nasopore product did not fragment after the patient had irrigated the product with saline spray.It was further reported that there were no adverse consequence for the patient or delays to surgery as a result of the reported event.It was also reported that the surgery was completed successfully.
Additional Manufacturer Narrative
The reported event, for nasopore product too slow fragmentation, was not confirmed as the product was not returned for evaluation.Without the product, the root cause cannot be determined.It was reported in this case that patients reported to the surgeon that they are not consistently remembering to use the saline spray ¿a few¿ times a day.The associated product instruction for use(ifu) recommends the following; "for patients with dry sinuses, you may moisten the nasal dressing with saline before insertion.Stryker recommends that the patient starts saline irrigation (nose and sinus) 2- 3 times a day (or as prescribed) 48 hours after insertion/surgery." the quality investigation is complete.
Event or Problem Description
It was reported that post operatively that the nasopore product did not fragment after the patient had irrigated the product with saline spray.It was further reported that there were no adverse consequence for the patient or delays to surgery as a result of the reported event.It was also reported that the surgery was completed successfully.Update; it was subsequently reported that patients informed the surgeon they are not consistently remembering to use the saline spray ¿a few¿ times a day.

• 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: 8611889
• Report Number: 0001811755-2019-01686
• Device Sequence Number: 16583567
• Product Code: LYA
• UDI-Device Identifier: 37613154340805
• UDI-Public: 37613154340805
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K052099
• 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): 06/20/2019

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?: No
• Initial Date Received by Manufacturer: 04/29/2019
• Supplement Date Received by Manufacturer: 06/20/2019
• Initial Report FDA Received Date: 05/15/2019
• Supplement Report FDA Received Date: 06/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1