MAUDE Adverse Event Report: ARTHROCARE CORP. STAMMBERGER SINUS DRESSING; SPLINT, INTRANASAL SEPTAL

Model Number	RR 650
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/30/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that despite mixing the stammberger sinufoam rr650 with sterile water as she had in the past, it did not dissolve but stayed in its full form.There was no patient injury reported.There was no backup device available.
Additional Manufacturer Narrative
The product, intended for use in treatment, was returned for evaluation.There is no relationship between the returned product and the reported event.The syringes returned were empty and did not have any material present; therefore, the complaint could not be verified and the root cause could not be determined with confidence.Factors that could have led to the device not dissolving includes: not using the recommended amount of sterile lactated ringer solution or sterile water which could result in more or less viscous dressing, not completing the recommended number of transfers between the small syringe into the syringe containing the cmc knit, or ensuring enough force is supplied in completing the transfers between the 2 syringes.There are no indications that would suggest the product did not meet product specifications upon release into distribution.

• Brand Name: STAMMBERGER SINUS DRESSING
• Common Device Name: SPLINT, INTRANASAL SEPTAL
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 7083033
• Report Number: 3006524618-2017-00391
• Device Sequence Number: 11236598
• Product Code: LYA
• UDI-Device Identifier: 00817470000412
• UDI-Public: (01)00817470000412(17)190228(10)4100483
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2018

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 Expiration Date: 02/28/2019
• Device Model Number: RR 650
• Device Catalogue Number: RR 650
• Device Lot Number: 4100483
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2017
• Initial Date Received by Manufacturer: 12/01/2017
• Supplement Date Received by Manufacturer: 02/02/2018
• Initial Report FDA Received Date: 12/05/2017
• Supplement Report FDA Received Date: 02/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1