SAGITTAL BLADE 18.0X1.27X100MM

Report

Report Number: 0001811755-2013-01813
Event Type: Injury
Date Received: August 2, 2013
Date of Event: July 16, 2013
Report Date: July 17, 2013
Manufacturer: STRYKER INSTRUMENTS-KALAMAZOO
Product Code: GFA
PMA / PMN Number: EXEMPT
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MS, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

THE FAILURE WAS CONFIRMED. THE DEFINITIVE ROOT CAUSE OF THE ISSUE REMAINS UNKNOWN, HOWEVER, THE EVALUATION OF THE RETURNED BLADE DETERMINED THAT THE BLADE WAS MIS-LOADED INTO THE HANDPIECE AT SOME POINT. IT CANNOT BE DETERMINED IF THE BLADE WAS USED WHEN IT WAS MIS-LOADED, BUT THIS POTENTIALLY CONTRIBUTED TO THE BLADE BREAK.

Additional Manufacturer Narrative · 1

DEVICE NOT RECEIVED.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE BLADE BROKE DURING A PROCEDURE. THERE WAS A 10 MINUTE DELAY WHILE THE PATIENT HAD AN X-RAY TAKEN TO DETERMINE NO BROKEN PIECES WERE IN THE PATIENT. THE BROKEN PIECES WERE RECOVERED FROM THE FLOOR. THE CASE WAS COMPLETED SUCCESSFULLY AND THERE WERE NO FURTHER ADVERSE CONSEQUENCES ASSOCIATED WITH THIS EVENT.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE BLADE BROKE DURING A PROCEDURE. THERE WAS A 10 MINUTE DELAY WHILE THE PATIENT HAD AN X-RAY TAKEN TO DETERMINE NO BROKEN PIECES WERE IN THE PATIENT. THE BROKEN PIECES WERE RECOVERED FROM THE FLOOR. THE CASE WAS COMPLETED SUCCESSFULLY AND THERE WERE NO FURTHER ADVERSE CONSEQUENCES ASSOCIATED WITH THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
363638	SAGITTAL BLADE 18.0X1.27X100MM	BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL	GFA	STRYKER INSTRUMENTS-KALAMAZOO		UNKNOWN

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other