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

Model Number 1884012HR

Device Problem Material Separation (1562)

Patient Problems Radiation Exposure, Unintended (3164); Device Embedded In Tissue or Plaque (3165)

Event Date 12/11/2019

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

A health care provider (hcp) reported via a manufacturer representative that in the middle of a septoplasty procedure, the external tip of the product broke off and was first noticed by the nurse when she received it back from the surgeon.When the surgeon checked the nasal cavity, he could not find the tip.After an extensive search and laryngeal mask airway (lma) was removed, x-ray was done and confirmed that the missing tip was in the patient¿s stomach.A replacement device was used to finish the procedure.There was a 30-minute delay in the procedure as a result of this event.It was noted that the broken piece remained inside the patient's body.The patient was discharged from theatre.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

On follow-up, it was reported that the broken piece was under observation to be passed out by the patient per rectum.

Manufacturer Narrative

H3: analysis found that visually, the middle assembly tip broke off at the spiral wrap and the inner spiral wrap was deformed which would have resulted in the reported event.The broken tip was not returned.There was minor deformation of the hubs which may be an indication of excess speed or improper direction.The inner assembly spun freely but was clicking each revolution.There was no damage to the inner assembly cutting teeth.The middle assembly spun freely by hand.There were no signs of an interference fit between assemblies.There was no allegation of a defect prior to use.The manufacturing instructions contain checks for damage to the components and finished assemblies in multiple locations and verifies proper rotation of the device in two steps.The information most likely indicates irregular torsional loads from improper speed or direction resulted in the observed damage.The product labeling indicates the maximum recommended speed for this device is 7500 rpm in oscillate mode.The user¿s guide warns ¿powered blades should be operated in the oscillate mode only.Operating in the forward mode may cause damage to the blade.¿ h6: fdm 4114, fdr 3221 and fdc 67 are no longer applicable.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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

On follow-up, it was reported that the patient was discharged without complications.There was no physical confirmation if the fragment was expelled.There were no residual effects noted.

• 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
• MDR Report Key: 9537825
• MDR Text Key: 173701180
• Report Number: 1045254-2020-00004
• Device Sequence Number: 1
• Product Code: EQJ
• UDI-Device Identifier: 00885074080604
• UDI-Public: 00885074080604
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1884012HR
• Device Catalogue Number: 1884012HR
• Device Lot Number: 0217663583
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2020
• Date Manufacturer Received: 04/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention