FDA Adverse Event Malfunction Summary report: N

NORIAN ROTARY MIXER

MDR report key: 3083323 · Received April 29, 2013

Report

Report Number: 2939274-2013-10008
Event Type: Malfunction
Date Received: April 29, 2013
Report Date: October 12, 2011
Manufacturer: NORIAN
Product Code: MQV
PMA / PMN Number: K011897
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: SZ
Reporter Occupation: OTHER

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. THE LOT NUMBER PROVIDED COULD NOT BE VERIFIED; THEREFORE, FURTHER INVESTIGATION CANNOT BE PERFORMED. ORIGINAL AWARENESS DATE IS (B)(6) 2011, NEW INFORMATION WAS RECEIVED ON (B)(6) 2012. PLACEHOLDER.

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. THE DEVICE WAS RETURNED FOR A MANUFACTURING EVALUATION AND HAD NO ISSUES UPON RECEIPT. THE SUPPLIER PERFORMED AN EVALUATION AND FOUND THAT THE DEVICE WAS WITHIN SPECIFICATION. THIS COMPLAINT IS INVALID FROM A MANUFACTURING STANDPOINT. PLACEHOLDER.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE NORIAN MIXER DID NOT TRANSFER THE PASTE INTO THE DELIVERY SYRINGE PROPERLY. THIS REPORT IS FOR FILE (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
184088	NORIAN ROTARY MIXER		MQV	NORIAN		N001955

Patients

Seq	Age	Sex	Outcome	Treatment
1