CORE SUMEX DRILL

Report

Report Number: 0001811755-2014-02335
Event Type: Malfunction
Date Received: June 30, 2014
Date of Event: June 3, 2014
Report Date: June 3, 2014
Manufacturer: STRYKER INSTRUMENTS-KALAMAZOO
Product Code: ERL
PMA / PMN Number: K040300
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MI, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

DURING FAILURE ANALYSIS, THE REPORTED EVENT WAS NOT DUPLICATED; HOWEVER, IT WAS CONFIRMED DURING SERVICE EVALUATION. THE PROBABLE CAUSE OF THE ISSUE WAS DETERMINED TO BE A DAMAGE OF THE CABLE ASSEMBLY.

Additional Manufacturer Narrative · 1

FAILURE ANALYSIS IS IN PROGRESS. A FOLLOW-UP WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION IS COMPLETE. DEVICE EVALUATION IN PROGRESS.

Description of Event or Problem · 1

DURING SERVICE INSPECTION AT THE MANUFACTURING FACILITY, IT WAS REPORTED THAT THE CORE SUMEX DRILL DISPLAYED A BIAS CURRENT MESSAGE WHEN CONNECTED TO THE CONSOLE, SIGNALING A CONDITION OCCURRED FROM WHICH THE DEVICE HAS THE POTENTIAL TO RUN WITHOUT USER ACTIVATION. NO PATIENT INVOLVEMENT, NO ADVERSE CONSEQUENCES, NO MEDICAL INTERVENTION, AND NO SURGICAL DELAY WERE REPORTED WITH THIS EVENT.

Description of Event or Problem · 1

DURING SERVICE INSPECTION AT THE MANUFACTURING FACILITY, IT WAS REPORTED THAT THE CORE SUMEX DRILL DISPLAYED A BIAS CURRENT MESSAGE WHEN CONNECTED TO THE CONSOLE, SIGNALING A CONDITION OCCURRED FROM WHICH THE DEVICE HAS THE POTENTIAL TO RUN WITHOUT USER ACTIVATION. NO PATIENT INVOLVEMENT, NO ADVERSE CONSEQUENCES, NO MEDICAL INTERVENTION, AND NO SURGICAL DELAY WERE REPORTED WITH THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
380560	CORE SUMEX DRILL	DRILL, SURGICAL, ENT (ELECTRIC OR PNUMATIC) INCLUDING HANDPIECE	ERL	STRYKER INSTRUMENTS-KALAMAZOO

Patients

Seq	Age	Sex	Outcome	Treatment
1