FDA Adverse Event Injury Summary report: N

*

MDR report key: 2912975 · Received January 10, 2013

Report

Report Number
2912975
Event Type
Injury
Date Received
January 10, 2013
Date of Event
January 7, 2013
Report Date
January 10, 2013
Manufacturer
SYNTHES
Product Code
JDQ
Adverse Event
Yes
Product Problem
Yes
Report Source
User Facility report
Reporter Location
AZ, US

Narratives

Description of Event or Problem · 1

PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION LEFT PERIOPROSTHETIC FEMUR FACTURE LAST FALL. PATIENT DID WELL UNTIL ONE WEEK PRIOR WHEN SHE DEVELOPED INCREASING PAIN. PAIN CONTINUED TO INCREASE TO THE POINT SHE WAS UNABLE TO AMBULATE. IN THE ED, X-RAYS WERE TAKEN AND PATIENT WAS FOUND TO HAVE BROKEN PROXIMAL CERCLAGE CABLES. PATIENT UNDERWENT A REVISION OPEN REDUCTION INTERNAL FIXATION. DURING THE PROCEDURE, THE 2 MOST PROXIMAL UNICORTICAL LOCKING SCREWS WERE ALSO NOTED TO BE COMPLETELY OUT OF THE PLATE AND IN SOFT TISSUE. THE SCREWS AND THE CABLES WERE REMOVED. THERE WAS NOTED TO BE SHORTENING AT THE FRACTURE AND TRACTION WAS APPLIED TO REALIGN THE UNICORTICAL LOCKING SCREW HOLES WITH THE LOCKING HOLES ON THE PLATE. A SINGLE CORTICAL NON-LOCKING SCREW WAS THEN PLACED AT THE PROXIMAL FRACTURE FRAGMENT WHICH BROUGHT THE PLATE DOWN TO BONE AND TEMPORARILY HELD THE FRACTURE. ATTENTION WAS THEN TURNED TO FURTHER SCREW FIXATION OF THE PROXIMAL FRAGMENT. OFFSET LOCKING ATTACHMENT DEVICES WERE PLACED PROXIMAL AND DISTAL AT THE PROXIMAL FRAGMENT. AT THE MOST DISTAL OFFSET ATTACHMENT 2 LOCKING SCREWS WERE PLACED. BOTH OF THESE SCREWS WERE ABLE TO OBTAIN BICORTICAL PURCHASE AVOIDING THESE FEMORAL STEM. AN ADDITIONAL SINGLE LOCKING SCREW WAS PLACED AT THE PROXIMAL OFFSET ATTACHMENT. THIS SCREW ALSO OBTAINED BICORTICAL PURCHASE. A TIBIAL CORTICAL STRUT WAS THEN OPENED. THE STRUT MEASURED 16 CM. THE STRUT WAS SCULPTURED USING THE OSCILLATING SAW. TWO 2 MM CABLES WERE PLACED PROXIMALLY TO THE FRACTURE AND 2 ADDITIONAL CABLES WERE PLACED DISTAL TO THE FRACTURE TO SECURE THE STRUT TO BONE. NOTED PRIOR TO FIXATION THERE WAS ADDITIONAL COMMINUTING AT THE FRACTURE SITE THAT HAD NOT BEEN PRESENT AT THE INITIAL FIXATION. FLUOROSCOPY WAS THEN AGAIN USED TO CONFIRM PROPER FIXATION AND ALIGNMENT OF THE FRACTURE SITE. TWO ADDITIONAL DISTAL LOCKING SCREWS WERE PLACED. IT WAS ALSO NOTED ON THE INITIAL APPROACH THAT THERE WAS EARLY CALLUS FORMATION AT THE FRACTURE SITE. THERE WAS ALSO NOTED TO BE SOME STRIPPING OF THE COMMINUTING FRAGMENTS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
16159 * CERCLAGE FIXATION JDQ SYNTHES * P125974
16160 CERCLAGE CABLE WITH CRIMP CERCLAGE, FIXATION JDQ SYNTHES * P125974

Patients

Seq Age Sex Outcome Treatment
1 78 YR Hospitalization| O| R NO OTHER THERAPIES