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

Model Number 1883672HS

Device Problems Break (1069); Overheating of Device (1437)

Patient Problem Burn, Thermal (2530)

Event Date 07/24/2017

Event Type  malfunction  

Manufacturer Narrative

Product evaluation: the hs bur was received for analysis.Visually, there was some discoloration of the outer tube just proximal to the radius that is consistent with excess heat as indicated by the customer.The inner assembly was stretched out of the outer tube support area by approximately 0.19¿ which indicates spiral wrap damage.The inner assembly was turned using the inner hub and the tip did not move indicating spiral wrap breakage.The proximal end of the inner assembly was removed and the location of the spiral wrap break corresponded to the discoloration observed on the outer tube.The hub bushings were gouged and worn.There were striations on the inner shaft 0.64¿ from the distal face of the inner hub.The inside diameter of the outer tube at the distal was worn with corresponding damage to the inner assembly.The information is consistent with heat induced resistance / breakage brought on by excess friction between the inner and outer assemblies.Note: the customer indicated that they used an m5 handpiece; this handpiece has a top speed of 30,000 rpm, however, this product has a maximum recommended speed of 12,000 rpm.The ifu contains warnings that excessive pressure applied to bur may cause damage, bending or prying may break the blade or bur, and, do not use burs above the speed indicated on the bur label.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

During a maxillectomy, an m5 microdebrider was being used to run a 70-degree 4mm high speed diamond bur when the bur "overheated in the curved section and caused a thermal injury to the patient¿s left nostril.It was noted that after this occurred, the user looked at the bur and found that "the flexible shaft inside [the bur] is severed, [it was assumed] it stopped spinning.A dark spot on the curved section was noted when it was removed.The thermal injury was "treated with topical antibiotic ointment"; the available information indicates that the thermal injury is considered resolved; nothing further reported by the patient.There was no report of a serious injury.

• Brand Name: XPS® BUR
• 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: 6848913
• MDR Text Key: 85145032
• Report Number: 1045254-2017-00310
• Device Sequence Number: 1
• Product Code: EQJ
• UDI-Device Identifier: 00721902100567
• UDI-Public: 00721902100567
• 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,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1883672HS
• Device Catalogue Number: 1883672HS
• Device Lot Number: 0212680886
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2017
• 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
• Patient Age: 40 YR
• Patient Weight: 83