FDA Adverse Event Injury Summary report: N

LEGEND

MDR report key: 4102152 · Received September 19, 2014

Report

Report Number: 1625507-2014-00052
Event Type: Injury
Date Received: September 19, 2014
Date of Event: August 25, 2014
Report Date: August 25, 2014
Manufacturer: MDT POWERED SURGICAL SOLUTIONS
Product Code: HBE
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

REPORT CONFIRMED. EVALUATION DETERMINED THAT THE TIP OF THE TOOL WAS DETACHED AND MISSING. IT WAS NOTED THAT AREA AROUND THE SEPARATION WAS CHARRED, AND SOME MATERIAL WAS MISSING FROM THE FRACTURE SITE. THE MATERIAL LOSS IS CONSISTENT WITH SPARK EROSION. IT IS SUSPECTED THAT THE TOOL CAME INTO CONTACT WITH A DISCHARGING ELECTRO-SURGICAL DEVICE NEAR THE TOOL HEAD WHILE THE TOOL WAS ROTATING. WE WILL CONTINUE TO TRACK AND TREND THIS COMPLAINT TYPE. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT "INITIAL OPERATION WAS PERFORMED. DURING THE OPERATION, THE DISTAL TIP OF THE BURR THAT WAS DEVICE FAILURE AND USED FOR TENTING WAS BROKEN. AFTER THE OPERATION, X-RAY PHOTOGRAPH SHOWED THAT THE BROKEN PART OF THE BURR REMAINED IN THE PATIENT BODY SO THAT ANOTHER OPERATION FOR REMOVAL OF THE FRAGMENT WAS CARRIED OUT. IT WAS SUCCESSFUL IN THE OPERATION...THE TOOL WAS USED FOR DP." NO PATIENT IMPACT REPORTED. ON FOLLOW-UP, IT WAS REPORTED THAT THE DEVICE WAS USED WITH AN EM200 MOTOR AND AN AS10 ATTACHMENT. IT WAS STATED THAT THE PATIENT HAD RECOVERED FROM THE PROCEDURE. FURTHER INFORMATION ABOUT THE TYPE OF PROCEDURE, AND IDENTIFYING INFORMATION ABOUT THE PATIENT COULD NOT BE OBTAINED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
584240	LEGEND	DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)	HBE	MDT POWERED SURGICAL SOLUTIONS	N/A	0006960547

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention	AS10, EM200