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

Model Number 1884016HR

Device Problems Break (1069); Device Damaged Prior to Use (2284); Component Missing (2306); Device Contamination With Biological Material (2908)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/31/2014

Event Type  malfunction  

Event Description

It was reported ¿right when the procedure was starting, the facility opened the package and found the blade to be broken.The end of the blade was unraveled.Nothing was detached from the blade.There was no patient impact as a result of this.¿ when the product was returned for analysis, it was found with bio-residue, a stretched spiral wrap, and missing the tip of the inner shaft.

Manufacturer Narrative

This device is used for therapeutic purposes.(b)(4).The product analysis found that there was evidence of biological contaminants [based off of the reactivity with hydrogen peroxide] and the device was returned in a biohazard bag.The finished goods packaging was not returned.Both hubs were extensively melted which is consistent with sterilization and therefore the device integrity was not intact which prevents an underlying cause from being determined.The inner and outer spiral wraps were broken in multiple locations which would have resulted in the reported malfunction.The tip of the middle tube assembly was broke off [due to the spiral wrap breakage] and not returned.When viewed under magnification, there was no definitive evidence to indicate a cause.The customer states they opened the package and found the blade to be broken; based off of the observations above the returned device condition is not consistent with the reported event.Method: microscopic inspection.Results: stress problem.

• Brand Name: RAD® ROTATABLE BLADE
• Type of Device: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC XOMED, INC; 6743 southpoint blvd north; jacksonville FL 32216
• Manufacturer (Section G): MEDTRONIC XOMED, INC.; 6743 southpoint drive north; jacksonville FL 32216
• Manufacturer Contact: amy corrales ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328138
• MDR Report Key: 4090334
• MDR Text Key: 4827520
• Report Number: 1045254-2014-00222
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/01/2014

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 Model Number: 1884016HR
• Device Catalogue Number: 1884016HR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2014
• Initial Date Manufacturer Received: 08/21/2014
• Initial Date FDA Received: 09/15/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1