FDA Adverse Event Malfunction Summary report: N

8MM TI CANNULATED TIBIAL NAIL EX/330MM

MDR report key: 3121651 · Received May 3, 2013

Report

Report Number
3121651
Event Type
Malfunction
Date Received
May 3, 2013
Date of Event
April 22, 2013
Report Date
May 3, 2013
Manufacturer
SYNTHES GMBH
Product Code
JDS
Product Problem
Yes
Report Source
User Facility report
Reporter Location
FL, US
Reporter Occupation
NURSE

Narratives

Description of Event or Problem · 1

THE PATIENT "WITH A RIGHT DISTAL TIBIA FRACTURE, UNDERWENT INTRAMEDULLARY RODDING LAST SUMMER AND CURRENTLY, DEVELOPED A HYPERTROPHIC NONUNION. ULTIMATELY WALKED ON THIS HYPERTROPHIC NONUNION AND BROKE THE SCREWS AND IMPALED THE DISTAL PORTION OF THE NAIL INTO THE TIBIOTALAR JOINT. UNDERWENT OPERATIVE REVISION FOR REMOVAL OF THE SYNTHES NAIL PLACEMENT OF AN 11X345 MM NAIL, STATICALLY LOCKED. INTRAOPERATIVE FINDINGS NOTED THAT THE SUBSEQUENT FRACTURE WAS UNITED ALTHOUGH IT WAS IN SLIGHT VARUS AND RECURVATUM, BUT STABLE. THE PATIENT AT THIS POINT IN TIME TOLERATED THE PROCEDURE WELL. NEUROVASCULARLY INTACT IN BILATERAL LOWER EXTREMITIES.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?EXCHANGE INTRAMEDULLARY RODDING RIGHT TIBIA USING A SYNTHES 11 X 345 MM ROD, STATICALLY LOCKED PROXIMALLY WITH 1 SCREW STATICALLY LOCKED DISTALLY WITH AN AP AND A MEDIAL AND LATERAL SCREW.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.DEVICE #2IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.DEVICE #3IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
195467 8MM TI CANNULATED TIBIAL NAIL EX/330MM NAIL JDS SYNTHES GMBH 04.004.246S 5801333
195468 * SCREW HWC SYNTHES GMBH 4.0 MM TI LOCKING SCREW 32 MM 6616613
195469 4.0 TI LOCKING SCREW W/T25 28MM SCREW HWC SYNTHES GMBH * 5812046
195470 4.0MM TI LOCKING SCREW W/T25 38MM SCREW HWC SYNTHES GMBH * 6602685
195471 4.0MM TI LOCKING SCREW W/T25 32MM SCREW HWC SYNTHES GMBH * 6616613

Patients

Seq Age Sex Outcome Treatment
1 42 YR