MAUDE Adverse Event Report: MDT PUERTO RICO OPERATIONS CO CURVED SINUS BURS; BUR, EAR, NOSE AND THROAT

Model Number 1883672HS

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/12/2014

Event Type  Injury  

Event Description

It was reported that a high speed bur was broken.During a lothrop procedure, the bur was turning in the handpiece which caused the doctor to re-calibrate it more often.Then the bur broke off in the patient's nose.Using forceps, the broken tip was successfully retrieved from the patient¿s nose.

Manufacturer Narrative

Concomitant medical products: 1898200t, microdebrider igs m4, manufacture date: unknown; serial number: unknown, 510k number: (b)(4).

Manufacturer Narrative

The product was evaluated by the quality engineering team.Received sample with original opened pouch and labels.The condition of the device showed customer use as there was presence of contaminants on the bur head.Observations: from visual evaluation, the spiral wrap was found broken near the tip.The spiral wrap hyperextension, unraveling, or breaking is indicative of possible procedural / anatomical / operational factors encountered by the customer during procedure which may have led to the failure observed on the device.These factors include and are not limited to difficult anatomical location, hard bone/tissue structure.These factors can cause the customer to exert pressure, manipulate and/or maneuver the device in a manner that may lead to hyperextension or breakage of the spiral wrap assembly.Based on the above observations the most likely underlying cause is related with 'operational context' as it is possible that customer maneuvering / manipulation of the device due to possible procedural / anatomical / operational factors encountered during the procedure may have led to the failure event.Methods ¿ actual device evaluated; visual inspection.Results ¿ operational problem; stress problem.Conclusions ¿ operational context caused or contributed to event.

Manufacturer Narrative

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

• Brand Name: CURVED SINUS BURS
• Type of Device: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC XOMED, INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer Contact: charlotte ayala ; 6743 southpoint dr n; jacksonville, FL 32216 ; 9043328372
• MDR Report Key: 4298722
• MDR Text Key: 16859725
• Report Number: 3004209178-2014-22624
• Device Sequence Number: 1
• Product Code: EQJ
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative,company represent
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/12/2014

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 Expiration Date: 09/09/2021
• Device Model Number: 1883672HS
• Device Catalogue Number: 1883672HS
• Device Lot Number: H8978312
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/09/2014
• Initial Date FDA Received: 12/04/2014
• Supplement Dates Manufacturer Received: Not provided; 12/09/2014
• Supplement Dates FDA Received: 12/31/2014; 09/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2013
• 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: 00043 YR