FDA Adverse Event Malfunction Summary report: N

BENDING IRON F/RODS Ø5.5 LE F/CORONAL PL

MDR report key: 3163266 · Received June 11, 2013

Report

Report Number: 8030965-2013-03064
Event Type: Malfunction
Date Received: June 11, 2013
Date of Event: December 7, 2011
Report Date: November 28, 2011
Manufacturer: SYNTHES GMBH
Product Code: HXW
PMA / PMN Number: EXEMPT
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NO
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. THE DEVICE LISTED IN THIS REPORT IS 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 INSPECTION AND THE EVENT WAS CONFIRMED. THE FRACTURE FACE IS HOMOGENOUS, WHICH INDICATES MATERIAL CONFORMITY. A REVIEW OF THE DHR INDICATES THERE WERE NO ANOMALIES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THIS COMPLAINT. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE PRESENT BENDING IRON WAS ANALYZED FOR CONFORMANCE TO PRINT SPECIFICATIONS AS WELL AND NO ABNORMAL FINDINGS WERE IDENTIFIED. MANUFACTURING AND INSPECTION RECORDS INDICATED NO PROBLEMS WITH THE LOT IN QUESTION. CONCLUSION ¿ THE COMPLAINT IS CONSIDERED INDETERMINATE FROM A MANUFACTURING PERSPECTIVE. WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF THIS OCCURRENCE AND CAN ONLY ASSUME THAT A MECHANICAL OVERLOAD CAUSED THIS BREAKAGE.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE INSTRUMENT BROKE DURING THE PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
263644	BENDING IRON F/RODS Ø5.5 LE F/CORONAL PL		HXW	SYNTHES GMBH		T939100

Patients

Seq	Age	Sex	Outcome	Treatment
1