MAUDE Adverse Event Report: MEDTRONIC XOMED INC. XPS® BLADE; BUR, EAR, NOSE AND THROAT

Model Number 1884005HRE

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/27/2016

Event Type  malfunction  

Manufacturer Narrative

When compared to the assembly drawing: visually, the tip of the inner cutter broke off which would have resulted in the reported event.The tip measured approximately 0.22 long.The break points correspond to the first proximal valley of the inner blade teeth.There were no signs of excess pressure being applied during use or improper loading of the blades into the handpiece.The deformation of the breaks is consistent with the inner tip contacting the outer tip during use.For this break to occur, the tip(s) configuration would have had to be or become deformed.One of the most likely causes is "aggressive use-case/handling condition with a part that has a thinner than expected wall thickness area where the breaks are occurring".A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the tip of the blade broke off during use.There was no patient impact.

Manufacturer Narrative

Age at time of event: (b)(6) sex: male, weight: (b)(6).Date of this event: (b)(6) 2016.Date of this report: (b)(6) 2016.Describe event or problem: additional information: the tip broke inside the patient's nasal cavity.It was retrieved by the surgeon.There was no patient injury.Rpt.Sent to fda? yes medwatch received for this event: (b)(6).Date manufacturer received: 11/16/2016.

Event Description

Additional information: the tip broke inside the patient's nasal cavity.It was retrieved by the surgeon.There was no patient injury.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: XPS® BLADE
• Type of Device: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr north; jacksonville FL 32216
• Manufacturer (Section G): MEDTRONIC XOMED INC.; 6743 southpoint dr north; jacksonville FL 32216
• Manufacturer Contact: michelle alford ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328197
• MDR Report Key: 6106224
• MDR Text Key: 60025147
• Report Number: 1045254-2016-00389
• Device Sequence Number: 1
• Product Code: EQJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/24/2016

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 Expiration Date: 07/20/2019
• Device Model Number: 1884005HRE
• Device Catalogue Number: 1884005HRE
• Device Lot Number: 0209892449
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/24/2016
• Initial Date FDA Received: 11/16/2016
• Supplement Dates Manufacturer Received: Not provided; 11/16/2016
• Supplement Dates FDA Received: 11/18/2016; 09/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/21/2015
• 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
• Patient Age: 52 YR
• Patient Weight: 89