CORE IMPACTION DRILL

Report

Report Number: 0001811755-2013-00177
Event Type: Malfunction
Date Received: February 5, 2013
Date of Event: January 14, 2013
Report Date: January 17, 2013
Manufacturer: STRYKER INSTRUMENTS-KALAMAZOO
Product Code: DZJ
PMA / PMN Number: K040369
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: OR, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

FAILURE ANALYSIS IS IN PROGRESS; ADDITIONAL INFORMATION WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION IS COMPLETED. FAILURE ANALYSIS IS IN PROGRESS.

Additional Manufacturer Narrative · 1

DURING THE DEVICE EVALUATION, THE DEVICE WAS FOUND TO HAVE A NUMBER OF CORRODED COMPONENTS, INCLUDING THE DRIVESHAFT BEARINGS. INCREASED FRICTION DUE TO CORROSION IS A PROBABLE CAUSE OF THE REPORTED OVERHEATING.THE REPORTED LEAKING COULD NOT BE CONFIRMED. HOWEVER, THE CORROSION FOUND WITHIN THE DEVICE MAY HAVE BEEN CAUSED BY CLEANING RESIDUE WITHIN THE DEVICE, WHICH CAN BE CAUSED BY CERTAIN STERILIZATION AND CLEANING PRACTICES BY THE USER FACILITY, AND MAY HAVE LED TO THE REPORTED LEAKING.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE AT THE USER FACILITY, THE DRILL WAS OVERHEATING AND LEAKING FLUID. NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE AT THE USER FACILITY, THE DRILL WAS OVERHEATING AND LEAKING FLUID. NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
47962	CORE IMPACTION DRILL	DRIVER, WIRE, AND BONE DRILL, MANUAL	DZJ	STRYKER INSTRUMENTS-KALAMAZOO

Patients

Seq	Age	Sex	Outcome	Treatment
1