MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. RAD® ROTATABLE BLADE; BUR, EAR, NOSE AND THROAT

Model Number 1884016HR

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/16/2014

Event Type  malfunction  

Manufacturer Narrative

The product analysis found that the spiral wrap failed and the tip broke off as a result which would have resulted in the reported malfunction.The extent of the spiral wrap damage may indicate the device was being run in forward direction however this cannot be confirmed.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.(b)(4).

Event Description

It was reported ¿the tip (outer tube) of the rad 60 curved blade broke off during ess (endoscopic sinus surgery), although no particularly strong pressure was applied while in use.Some debris were observed, but those did not remain in the patient's body.The procedure was continued using a back-up device and completed successfully without delay, with no adverse effect on the patient.¿ no additional procedures were required.

Manufacturer Narrative

This device is used for therapeutic purposes.(b)(4).

Manufacturer Narrative

Information was inadvertently left out of the previous supplemental mdr d.8.Yes g.4.The need for correction was noted on jan.7, 2015.

Event Description

Additional information was received from the sales rep: "i'm in the or with dr (b)(6) today and took the below picture which is a reprocessed rad60.He verified that some of the blades that have broken were reprocessed.He also verified that they were not used in fwd mode.As observation from today's case, his staff correctly set up and he used the rad60 at 5,000 osc mode without any product problems.".

Manufacturer Narrative

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

• Brand Name: RAD® ROTATABLE BLADE
• Type of Device: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC XOMED, INC; 6743 southpoint drive north; jacksonville FL 32216
• Manufacturer Contact: amy corrales ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328138
• MDR Report Key: 4251496
• MDR Text Key: 12704395
• Report Number: 3004209178-2014-21616
• 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,Followup
• Report Date: 10/21/2014

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: 06/20/2018
• Device Model Number: 1884016HR
• Device Catalogue Number: 1884016HR
• Device Lot Number: HG06C8B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/07/2015
• Initial Date FDA Received: 11/14/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; 01/07/2015
• Supplement Dates FDA Received: 12/15/2014; 01/07/2015; 09/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1