FDA Adverse Event Malfunction Summary report: N

MATRIXMANDIBLE TROCAR

MDR report key: 2982985 · Received February 26, 2013

Report

Report Number: 8030965-2013-10204
Event Type: Malfunction
Date Received: February 26, 2013
Date of Event: January 13, 2011
Report Date: January 14, 2011
Manufacturer: SYNTHES GMBH
Product Code: FZX
PMA / PMN Number: EXEMPT
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MI, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE DEVICE WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION NOTED SLIGHTLY RUSTY SPOTS NEXT TO THE MARKING. NO MANUFACTURING RELATED FAULT COULD BE DETECTED. THE CORROSION RESISTANCE OF STAINLESS STEEL IS MAINTAINED ONLY WHEN THE MATERIAL IS STORED ON A DRY AND METALLIC CONTACT-LESS CONDITION. HUMID OR WET CONDITIONS CREATE ELECTROLYTIC REACTIONS, WITH CONTACT CORROSION AS A RESULT. THEREFORE, IT WAS DETERMINED THAT THE REPROCESSING AND STORAGE OF THIS INSTRUMENT WAS NOT PERFORMED ACCORDING TO GUIDELINES. 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.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE DRILL BITS AND SCREW TRAY ARE RUSTING IN THE MANDIBLE SET. THERE WAS NO PT IMPACT, AS THE ISSUE WAS DISCOVERED OUTSIDE THE OPERATING ROOM WHEN STOCKING THE SET. THIS IS REPORT 1 OF 6 FOR THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
81097	MATRIXMANDIBLE TROCAR		FZX	SYNTHES GMBH		1631583

Patients

Seq	Age	Sex	Outcome	Treatment
1