MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. XPS® BLADE; BUR, EAR, NOSE AND THROAT

Model Number 1884012HR

Device Problem Stretched (1601)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/20/2017

Event Type  malfunction  

Manufacturer Narrative

The blade was received for analysis.Visually, the inner shaft was bent and a section of the inner spiral was included in a small bag which would have resulted in the reported event.The bend in the inner shaft was next to the distal face of the inner hub; the severity of the bend indicates that the device could not have been used if the defect were present prior to use; and therefore, it is likely the damage occurred during unloading of the blade from the handpiece or sometime after.The section of spiral wrap that was included in the bag measured approximately 0.24¿ long.Initially it could not be determined how the portion of the spiral wrap became detached because it should have been contained by the outer assembly; further analysis found that the outer cutter tip was not attached and slid off the end which would have exposed the spiral wrap.The detached portion of the tip measured approximately 0.44¿ long.When viewed under magnification there was damage to the teeth that is consistent with impact.There was no allegation of a defect prior to use.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

The physician reported that while using the rad 12 blade the inner cylinder of the device was broken.It was confirmed that after st retching, a fragment of the spiral wrap detached; however, it did not fall into the patient or require retrieval.A back-up blade was used to complete the procedure.There was no patient impact.

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 PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: michelle alford ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328197
• MDR Report Key: 6866822
• MDR Text Key: 86587076
• Report Number: 3004209178-2017-19377
• Device Sequence Number: 1
• Product Code: EQJ
• UDI-Device Identifier: 20885074080608
• UDI-Public: 20885074080608
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/19/2021
• Device Model Number: 1884012HR
• Device Catalogue Number: 1884012HR
• Device Lot Number: HG1LU5A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/18/2017
• Date Device Manufactured: 01/19/2017
• 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