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

Model Number 1882569HS

Device Problems Material Fragmentation (1261); Material Twisted/Bent (2981); Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/12/2019

Event Type  malfunction  

Manufacturer Narrative

Analysis found that there was a residue consistent with biological contaminants on both devices.The inner assembly of both samples would turn freely by hand however sample 1 inner tip broke off at the spiral wrap.The spiral wrap was twisted in on itself in a clockwise direction 0.79¿ from tip indicating torsion load and aggressive use.The tips of both samples were compacted with biological material with varying degrees which may require the user to apply more pressure to maintain performance.The distal end of the outer tubes inside diameter of both samples was rough and worn, sample 1 wore through the outer tube wall.The adjacent inner assemblies were rough and worn on both samples.If information is provided in the future, a supplemental report will be issued.

Event Description

A healthcare professional (hcp) reported via manufacturer representative that the bur was damaged and tip was bent during the endoscopic sinus surgery procedure.The tip came off and the product became unable to be used because it could not rotate.There were fragments detached from the device.There was no broken pieces remain inside the patient's body.There was no intervention planned or performed.There was no delay with the procedure.The procedure was completed with backup product(s).There was no patient impact.

• Brand Name: XPS® BLADE
• Type of Device: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer (Section G): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer Contact: christy cain ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328353
• MDR Report Key: 9637681
• MDR Text Key: 178627185
• Report Number: 1045254-2020-00060
• Device Sequence Number: 1
• Product Code: EQJ
• 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
• Report Date: 01/28/2020

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: 1882569HS
• Device Catalogue Number: 1882569HS
• Device Lot Number: 0218280981
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/10/2020
• Initial Date FDA Received: 01/28/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/14/2019
• 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