MAUDE Adverse Event Report: MDT PUERTO RICO OPERATIONS CO BUR 1883672HS 3PK HI SPEED DIAMOND 70DEG; BUR, EAR, NOSE AND THROAT

Model Number 1883672HS

Device Problems Fracture (1260); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/10/2014

Event Type  malfunction  

Event Description

It was reported that the ¿connection on the bur did not work, the blue part was loose.Used a second bur with no problem.No patient impact.¿ product analysis found that the inner shaft broke 0.673¿ from the distal face of the inner hub.

Manufacturer Narrative

This device is used for therapeutic purposes.(b)(4).Product evaluation: when received for analysis there was evidence of biological contaminants [based off of the reactivity with hydrogen peroxide].When compared to the assembly drawing: the inner shaft broke 0.673¿ from the distal face of the inner hub which would have resulted in the reported malfunction.The break point corresponds to the proximal end of the outer tube in the front hub.When viewed under magnification, there was deformation of the locking area on the front hub and striations around the outside diameter of the break point indicating metal on metal contact.The information indicates excess pressure was applied during use which caused the deformation of the locking area; which then caused the inner shaft and outer tube to rub together until the inner shaft broke.There was no indication of device fragments and the breakage would have been contained by the outer tube and the handpiece.Note: the observed damage has previously been reproduced by using excess force during use with a reserve sample blade.Instructions for use warn that excessive pressure applied to a bur/blade may cause a fracture.(b)(4).

• Brand Name: BUR 1883672HS 3PK HI SPEED DIAMOND 70DEG
• 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 drive north; jacksonville FL 32216
• Manufacturer Contact: michelle alford ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328197
• MDR Report Key: 3775782
• MDR Text Key: 20105681
• Report Number: 3004209178-2014-08179
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/03/2014

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: 10/03/2021
• Device Model Number: 1883672HS
• Device Catalogue Number: 1883672HS
• Device Lot Number: H9031294
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/03/2014
• Initial Date FDA Received: 04/28/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/03/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1