FDA Adverse Event Injury Summary report: N

UNIV-TIBNAIL Ø12 L380 SST

MDR report key: 2870531 · Received December 12, 2012

Report

Report Number: 2520274-2012-03858
Event Type: Injury
Date Received: December 12, 2012
Date of Event: April 16, 2008
Report Date: October 5, 2010
Manufacturer: SYNTHES
Product Code: JDS
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: PA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

DEVICE WAS USED FOR TREATMENT. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THIS INDIVIDUAL ADVERSE EVENT REPORT IS BEING MADE IN ACCORDANCE WITH THE SYNTHES MDR EXEMPTION REQUEST DATED (B)(4) 2011. A REVIEW OF THE EVENTS ASSOCIATED WITH THE REQUEST WAS PERFORMED AND IT WAS DETERMINED THAT NONE OF THE EVENTS CONSTITUTES SYSTEMIC ISSUES RELATED TO PRODUCT QUALITY, CHANGES IN PRODUCT DESIGN, METHOD OF USE, OR CHANGES IN EXPECTED RISK THRESHOLDS. REVIEW OF THE DATA ALSO INDICATED NO SIGNIFICANT CHANGE IN RISK/BENEFIT OF EACH PRODUCT CATEGORY, NO EVIDENCE OF DEFICIENCIES IN THE DESIGN, LABELING, OR MANUFACTURE OF THE DEVICE. AS NO LOT NUMBER WAS PROVIDED, NO DEVICE HISTORY RECORD REVIEW CAN BE PERFORMED. THE DEVICE IS NOT BEING RETURNED FOR EVALUATION, NO FURTHER INFORMATION IS AVAILABLE ON THIS EVENT. NO FURTHER INVESTIGATION CAN BE PERFORMED.

Description of Event or Problem · 1

(B)(6) COMPLAINT HANDLING UNIT REPORTED PATIENT WITH LEFT COMMINUTED DISTAL TIBIA AND FIBULA FRACTURE ON (B)(6) 2007. OP: INTERNAL FIXATION BY MEANS OF A UNIVERSAL TIBIAL NAIL DATE UNKNOWN, THREE MONTHS LATER THE NAIL WAS DYNAMIZED AND AUTOLOGOUS GRAFT WAS PUT IN THE FRACTURE ZONE. BREAKAGE OF THE UNIVERSAL TIBIAL NAIL ON (B)(6) 2008.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	UNIV-TIBNAIL Ø12 L380 SST		JDS	SYNTHES

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention