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

Model Number 1884012HR

Device Problem Material Fragmentation (1261)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/07/2014

Event Type  Injury  

Event Description

It was reported to me that the blade broke and a piece of it fell in the maxillary sinus.That piece was retrieved with an instrument causing a ten minute delay.It was noted that earlier in the case, the scrub nurse took the stylet to clean out the blade and the shaver pedal was accidentally pressed down, causing the blade to get stuck.The customer thought that this could have possibly done something internally but wasn¿t certain.After the stylet was removed it seemed to be working fine for a portion of the case.There was no injury to the patient.

Manufacturer Narrative

This device is used for therapeutic purposes.(b)(4).The device has been received and analysis is currently underway.(b)(4).

Manufacturer Narrative

As received condition: received 1 sample(s), part number 1884012hr.There was evidence of biological contaminants [based off of the reactivity with hydrogen peroxide].Equipment used: microscope (zeiss stemi 2000c between 0,65 to 5,0 magnification settings).Observations: when compared to the assembly drawing 66500090 revision g: the middle spiral wrap failed and the tip broke off as a result which would have resulted in the reported malfunction.When viewed under magnification, there was deformation of the front hub that is consistent with excess pressure being applied while in the handpiece.The extent of the spiral wrap damage may indicate the device was being run in forward direction however this cannot be confirmed.The instructions for use 68e4066 revision k warns: excessive pressure applied to bur/blade may cause fracture.Note: [excess: exceeded sufficient pressure required for operation].Additionally the instructions for use warns ¿powered blades should be operated in the oscillate mode only.Operating in the forward mode may cause damage to the blade.¿ there was no evidence of improper manufacturing therefore manufacturing has been ruled out as a potential cause.Method ¿ actual device evaluated; labeling evaluation; visual inspection fda; microscopic inspection; results: stress problem.Conclusion: operational context caused or contributed to event.

Manufacturer Narrative

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

• Brand Name: RAD® 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 north; jacksonville FL 32216
• Manufacturer Contact: charlotte ayala ; 6743 southpoint dr north; jacksonville, FL 32216 ; 9043328372
• MDR Report Key: 4214679
• MDR Text Key: 4997304
• Report Number: 1045254-2014-00280
• Device Sequence Number: 1
• Product Code: EQJ
• 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 Facility,Company Representative,company representati
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/07/2014

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 Model Number: 1884012HR
• Device Catalogue Number: 1884012HR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2014
• Initial Date FDA Received: 10/30/2014
• Supplement Dates Manufacturer Received: Not provided; 11/10/2014
• Supplement Dates FDA Received: 11/11/2014; 09/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 00031 YR
• Patient Weight: 95