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

Model Number 1882900

Device Problem Failure to Cut (2587)

Patient Problem Injury (2348)

Event Date 06/30/2015

Event Type  Injury  

Event Description

It was reported that 3 drill bits were used in a procedure to remove a frontal mucoele.Two of the bits snapped while connected to the m4 hand piece and being tested running at 12000rpm (recommended 6000rpm), prior to patient involvement.It was confirmed that no fragments were in contact with the sterile field; these were being tested away from the patient.The third drill bit did not snap, but did not penetrate the bone for which it is designed.This was while running at 6000rpm.They subsequently increased the power to 12000rpm but still the drill did not take to the bone.The procedure was not fully completed and a completion will most likely be scheduled for a later date.There was no impact to the patient.

Manufacturer Narrative

Blank fields on this report are the result of information not being provided by initial reporter.This device is used for therapeutic purposes.Concomitant medical products: 1895400: footswitch 1895400 xps, s/n (b)(4), lot 35328200 manufactured: 09/15/2004.1897102: console 1897102 xps 3000 2 pump, s/n (b)(4), lot 35127100 manufactured: 08/30/2004.1898200t: microdebrider 1898200t igs m4, s/n (b)(4), manufactured: 04/03/2008 (b)(4).Product evaluation: -- drill 1882900 mini trephination 2mm: no analysis results available; device not returned for evaluation.-- footswitch 1895400 xps: service and repair found that the cable is kinked, the pushbutton is damaged and does not work, the decal is damaged and the foot plate is bent which does not allow maximum speed to be reached.The foot plate was corrected, screw update was performed, decals were replaced and the cable was replaced.The device was successfully tested to specifications.-- console 1897102 xps 3000 2 pump: service and repair found that the display screen overlay is scratched and the bezel is damaged.The bezel and overlay have been replaced.The device was successfully tested to specifications.-- microdebrider 1898200t igs m4: no analysis results available; device not returned for evaluation.

Manufacturer Narrative

Initial report states: ¿they did run the drill at 12000rpm and are aware it should only be 6000rmp but say they always run at 12000rmp and have not had an issue before.¿ it has been confirmed that the outer label of the device states that the maximum speed this device can to be run is <(><<)>6000rpm.Date of this report: 06/30/2015.Device available for evaluation? yes return date: 08/11/2015.Date received by manufacturer: 08/13/2015.Product evaluation: -- drill (b)(4) mini trephination 2mm: when received for analysis, there was evidence of biological contaminants on one sample [based off of the reactivity with hydrogen peroxide].The samples were analyzed.Two of the samples had broken drill bit shafts.The shafts were fractured at the location where the drill bit exits the outer piece of the assembly.No material or manufacturing defects were found.The third sample was not broken but the customer claimed that this sample did not cut bone.All samples conformed to drawings including the cutting flutes.The alleged malfunction [not cutting] could not be confirmed.(b)(4).

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 drive north; jacksonville FL 32216
• Manufacturer Contact: michelle alford ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328197
• MDR Report Key: 4939669
• MDR Text Key: 6434611
• Report Number: 1045254-2015-00249
• Device Sequence Number: 1
• Product Code: EQJ
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/12/2023
• Device Model Number: 1882900
• Device Catalogue Number: 1882900
• Device Lot Number: 0209138675
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/30/2015
• Initial Date FDA Received: 07/24/2015
• Supplement Dates Manufacturer Received: 08/13/2015
• Supplement Dates FDA Received: 09/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/14/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 00066 YR