OSSEOFLEX 1.0 STEERABLE NEEDLE

MDR report key: 2011808 · Received February 23, 2011

Report

Report Number: 3007111981-2011-00001
Event Type: Other
Date Received: February 23, 2011
Date of Event: February 1, 2011
Report Date: February 5, 2011
Manufacturer: OSSEON THERAPEUTICS, INC.
Product Code: GAA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: GA, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

DEVICE AND PACKAGING WERE CLEARLY MARKED AS "DEMO/NOT FOR HUMAN USE" PER OSSEON PROCEDURES.

Description of Event or Problem · 1

THE SURGERY WAS RUNNING LATE AND THE SALES REP WAS OUT OF THE ROOM. AN OSSEON NEEDLE DEMO KIT WAS IN THE SALES REP'S SALES KIT BAG, WHICH WAS IN THE SUB STERILE LOCATION AWAY FROM THE OPERATING FIELD. THE SALES REP WAS WAITING IN THE WAITING ROOM FOR THE PROCEDURE. THE SALES REP WAS CALLED LATER BY THE SURGEON'S NURSE TO LET HIM KNOW THAT THEY WERE OPENING THE ROOM, I.E. BEGINNING THE PROCEDURE. THE SALES REP TOLD THE NURSE THAT HE WOULD BE THERE IN A FEW MINUTES. BY THE TIME THE SALES REP RETURNED, THE NURSE HAD REMOVED THE DEMO UNIT FROM THE SALES REP'S PRODUCT KIT. THE PRODUCT IS MARKED AS A DEMO UNIT, WITH "NOT FOR HUMAN USE" LABELS ON THE BOX AND NEEDLE, AND IS NOT STERILE. THE NURSE FAILED TO NOTICE THE "NOT FOR HUMAN USE" LABELS AND THE SYSTEM WAS PRESENTED TO THE DR FOR USE IN THE PT. THE SALES REP NOTICED THE ERROR WHILE HE WAS DOING THE PAPERWORK AFTER THE CASE. HE CALLED THE SURGEON BACK TO MAKE HIM AWARE OF THE SITUATION. THE SALES REP REPORTS THAT AS OF 4 DAYS AFTER THE PROCEDURE, THERE HAS BEEN NO IMPACT TO THE PT. THE PT WAS ALSO ADVISED OF THE PROBLEM.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	OSSEOFLEX 1.0 STEERABLE NEEDLE	OSSEOFLEX 1.0	GAA	OSSEON THERAPEUTICS, INC.	OF-0001

Patients

Seq	Age	Sex	Outcome	Treatment
1	81 YR		Other