FDA Adverse Event Malfunction Summary report: N

NORIAN ROTARY MIXER

MDR report key: 3003423 · Received February 28, 2013

Report

Report Number: 2939274-2013-10004
Event Type: Malfunction
Date Received: February 28, 2013
Date of Event: March 14, 2011
Report Date: March 16, 2011
Manufacturer: NORIAN
Product Code: MQV
PMA / PMN Number: K011897
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: UK
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE SUPPLIER'S DEVICE HISTORY RECORDS REVIEW INDICATED THAT THE UNIT MET SPECIFICATIONS WHEN IT WAS ORIGINALLY MANUFACTURED. PRODUCT EVALUATION DETERMINED THAT THE SPRING FORCE WAS TOO LOW. THE DEVICE WAS RECEIVED FOR EVALUATION AND THE SPRINGS APPEARED TO HAVE FATIGUED OVER TIME WITH USAGE. BECAUSE THE UNIT HAS BEEN IN THE FIELD FOR SIX YEARS, AND THIS IS THE FIRST REPORT FILED, IT IS LIKELY THAT THE SPRING FATIGUE CAN BE ATTRIBUTED TO NORMAL FIELD USAGE.

Description of Event or Problem · 1

A DEVICE REPORT RECEIVED FROM SYNTHES (B)(4) INDICATED THAT A PHYSICIAN EXPERIENCED AN ISSUE WITH THE NORIAN 3CC AND 5CC IN THE NORIAN ROTARY MIXER. PRODUCT DEVELOPMENT INVESTIGATION PERFORMED A TEST RUN WITH THE MIXER USING DEMO PRODUCT. AFTER 70 REVS THERE WAS STILL SOME POWDER VISIBLE. ALSO, ON THE FIRST TRY, ONLY 5CC OF THE 10CC WAS TRANSFERRED. ON THE SECOND TRY THEY PRESSED AN ADDITIONAL 3.5CC OUT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
86881	NORIAN ROTARY MIXER		MQV	NORIAN		01967

Patients

Seq	Age	Sex	Outcome	Treatment
1