MAUDE Adverse Event Report: MEDTRONIC XOMED INC. CURVED SINUS BURS; BUR, EAR, NOSE AND THROAT

Model Number 1883070HS

Device Problem Break (1069)

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

Event Date 11/27/2014

Event Type  malfunction  

Event Description

It was reported that three blades/burs were used in an ess procedure and malfunctioned.Bur (part # 1883070hs) disassembled into pieces while in use.The tip of the curved blade (part # 1884016hr) did not rotate from the start when the disc was turned.Therefore, the doctor had to detach the blade, turned the tip manually, and attach the blade again each time of changing the position.The device made a cracking sound while in use.After a while, the outer tube became unstable, the device stopped working and could not be used.During use the tip of bur (part #1883672hs) seemed to be somewhat extended, and thus the device could not be used.The doctor reported that the incident might be related to his way of handling the devices stating that the devices were firmly pressed onto the patient's bone.The devices were replaced by back-up devices, and the procedure was completed successfully without any delay or adverse effect.

Manufacturer Narrative

Concomitant products: 1884016hr: blade, rad 60, 4mm, m4 rotat 5/bx, lot # h8738275, manufactured date ¿ may/07/2013, expiration date ¿ may/07/2017.A 1883672hs: bur, 1883672hs 3pk hi speed diamond 70deg, lot #70181900, manufactured date - oct/28/2010, expiration date ¿ oct/18/2018.(b)(4).The product has been returned, evaluation is in progress.Results methods: no testing methods performed.Results pending completion of evaluation.This device is used for therapeutic purposes.(b)(4).

Manufacturer Narrative

A total of three samples (part # 1883070hs, part # 1884010hr and part # 1883672hs) were received for evaluation.Evaluation of bur (part # 1883070hs lot# 0207684059) found the spiral wrap assembly significantly hyperextended (stretched) and broken near the tip but the bur head remained intact and did not detach from the spiral wrap assembly.A small fragment of spiral wrap assembly was also found detached due to the significant damage observed on the shaft assembly.The bur tip was observed and no anomalies were found.There was no indication of customer misloading of device since no dimples were found on the hub.Based on previous complaints, the spiral wrap hyperextension is indicative of possible procedural / anatomical / operational factors encountered by the customer during procedure which may have led to the failure.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 inadvertent spiral wrap extension or breakage.There were no indications of customer misuse or manufacturing defects.Evaluation of blade (part # 1884010hr, lot # h8738275) found that the inner shaft and middle shaft assemblies were broken at the spiral wrap assembly, close to the location where the device is bent.The spiral wrap assembly appeared to have been hyperextended inside the outer shaft based on the abnormal extension of the tip exposed at the distal end.The broken shaft assemblies (inner and outer) were observed and were found broken where the shaft transitions to spiral wrap.Based on the breakage observed and previous investigations performed for similar failure (for spiral wrap breakage), the issue may likely be attributed to excessive force applied (sideloading) by the customer, possibly due to procedural / anatomical / operational factors encountered during the procedure which includes and is not limited to difficult anatomical location, hard bone/tissue structure.There was no evidence of manufacturing defects on the returned samples.There was also no obvious evidence present on the device for customer misuse / misloading.Evaluation of bur (part # 1883672hs, lot# 70181900) found that the spiral wrap assembly of the inner shaft was slightly hyperextended (stretched) near the tip but was not broken at any location.This minor hyperextension of spiral wrap assembly near the tip can occur due to possible procedural / anatomical / operational factors encountered by the customer during procedure.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 inadvertent spiral wrap extension.There were no indications of customer misuse or manufacturing defects.(b)(4).

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): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer (Section G): MEDTRONIC XOMED INC.; 6743 southpoint drive north; jacksonville FL 32216
• Manufacturer Contact: sharanya jangiti ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328183
• MDR Report Key: 4353276
• MDR Text Key: 5218892
• Report Number: 1045254-2014-00339
• Device Sequence Number: 1
• Product Code: EQJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/03/2021
• Device Model Number: 1883070HS
• Device Catalogue Number: 1883070HS
• Device Lot Number: 0207684059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/24/2014
• Initial Date FDA Received: 12/22/2014
• Supplement Dates Manufacturer Received: Not provided; 12/24/2014
• Supplement Dates FDA Received: 01/15/2015; 09/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/05/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 00040 YR