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U.S. Department of Health and Human Services

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

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MEDTRONIC PUERTO RICO OPERATIONS CO. XPS® BLADE BUR, EAR, NOSE AND THROAT Back to Search Results
Model Number 1883519HR
Device Problems Vibration (1674); Connection Problem (2900)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/26/2019
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
A health care provider (hcp) reported via a manufacturer representative that during a routine sinus surgery procedure, the inner portion of the blade has become loose and spins on its own without turning the blade. The procedure was completed with backup device. There was no patient impact or injury.
 
Manufacturer Narrative
Corrected from medtronic xomed inc. To medtronic puerto rico operations co. Analysis found that the inner assembly would spin, and middle would index freely by hand with no unusual resistance. There was no damage to the tip. When viewed under magnification, there was damage to the hubs that is consistent with improper or difficulty loading the device into the handpiece: locking area deformation caused by the back side of the front collet of the handpiece; and deformation of the proximal inner hub chevrons caused by the handpiece drive mechanism. The user¿s guide has detailed instructions for properly loading a bur/blade into the handpiece. There were no loose components. Even with the deformation of the hubs, functionally the device loaded securely into a handpiece, ran at the maximum recommended speed of 3,000 rpm in oscillate mode/direction, and cut saw bone with no issues. There was no allegation of a defect prior to use. A review of the xpi did not indicate any evidence to point to improper manufacturing and there are checks for damage throughout the process. A bur or blade that is not properly loaded would result in improper support from the handpiece, engagement with the suction seal, drive, and locking mechanism. If information is provided in the future, a supplemental report will be issued.
 
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Brand NameXPS® BLADE
Type of DeviceBUR, EAR, NOSE AND THROAT
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos,pr FL 00777
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos,pr FL 00777
Manufacturer Contact
christy cain
6743 southpoint drive north
jacksonville, FL 32216
9043328353
MDR Report Key8730531
MDR Text Key149079736
Report Number1045254-2019-00308
Device Sequence Number1
Product Code EQJ
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/24/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/25/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1883519HR
Device Catalogue Number1883519HR
Device Lot NumberHG2ZX73
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/23/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/23/2019
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

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