CORE IMPACTION DRILL

Report

Report Number: 0001811755-2014-02388
Event Type: Injury
Date Received: July 3, 2014
Date of Event: June 9, 2014
Report Date: June 10, 2014
Manufacturer: STRYKER INSTRUMENTS-KALAMAZOO
Product Code: DZJ
PMA / PMN Number: K040369
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE IS AVAILABLE FOR EVALUATION BUT HAS NOT YET BEEN RECEIVED. ADDITIONAL INFORMATION MAY BE SUBMITTED ONCE THE DEVICE IS RECEIVED AND THE QUALITY INVESTIGATION IS COMPLETE.

Additional Manufacturer Narrative · 1

PRODUCT RETURN UPDATED. AS THIS PRODUCT WAS NOT RETURNED FOR EVALUATION, THE FAILURE MODE COULD NOT BE CONFIRMED. DEVICE NOT RETURNED TO MANUFACTURER FOR INVESTIGATION.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING AN EXTRACTION PROCEDURE AT THE USER FACILITY, THE CORE IMPACTION DRILL OVERHEATED, CAUSING A 2 BY 5 CENTIMETER BURN TO THE LOWER LIP OF THE PATIENT. NEOSPORIN WAS APPLIED TO THE BURN. NO ADDITIONAL MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING BACK-UP EQUIPMENT WITHOUT A CLINICALLY SIGNIFICANT DELAY.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING AN EXTRACTION PROCEDURE AT THE USER FACILITY, THE CORE IMPACTION DRILL OVERHEATED, CAUSING A 2 BY 5 CENTIMETER BURN TO THE LOWER LIP OF THE PATIENT. NEOSPORIN WAS APPLIED TO THE BURN. NO ADDITIONAL MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING BACK-UP EQUIPMENT WITHOUT A CLINICALLY SIGNIFICANT DELAY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
390112	CORE IMPACTION DRILL	DRIVER, WIRE, AND BONE DRILL, MANUAL	DZJ	STRYKER INSTRUMENTS-KALAMAZOO

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other