Medical device manufacturer, Synthes, has issued a medical device safety alert concerning certain lots of the Transpedicular Schanz Screw as follows:-
1.Ø 5.0 mm, shaft Ø 5.0 mm, length 180/35 mm, Stainless Steel
2. Ø 6.0 mm, shaft Ø 5.0 mm, length 180/35 mm, Stainless Steel
3. Ø 7.0 mm, shaft Ø 5.0 mm, length 180/35 mm, Stainless Steel
4. Ø 5.0 mm, shaft Ø 5.0 mm, length 180/35 mm, Titanium Alloy (TAN), gold
5. Ø 6.0 mm, shaft Ø 5.0 mm, length 180/35 mm, Titanium Alloy (TAN), gold
6. Ø 5.0 mm with dual core, length 180/35 mm, Titanium Alloy (TAN), violet
7. Ø 5.0 mm with dual core, length 185/40 mm, Titanium Alloy (TAN), violet
8. Ø 5.0 mm with dual core, length 190/45 mm, Titanium Alloy (TAN), violet
9. Ø 5.0 mm with dual core, length 195/50 mm, Titanium Alloy (TAN), violet
10. Ø 5.0 mm with dual core, length 200/55 mm, Titanium Alloy (TAN), violet
11. Ø 6.2 mm with dual core, length 180/35 mm, Titanium Alloy (TAN), dark blue
12. Ø 6.2 mm with dual core, length 185/40 mm, Titanium Alloy (TAN), dark blue
13. Ø 6.2 mm with dual core, length 190/45 mm, Titanium Alloy (TAN), dark blue
14. Ø 6.2 mm with dual core, length 195/50 mm, Titanium Alloy (TAN), dark blue
15. Ø 6.2 mm with dual core, length 200/55 mm, Titanium Alloy (TAN), dark blue
16. Ø 7.0 mm, shaft Ø 5.0 mm, length 180/35 mm, Titanium Alloy (TAN)
Part no.:
1. 296.680
2. 296.690
3. 296.780
4. 496.680
5. 496.690
6. 496.711
7. 496.712
8. 496.713
9. 496.714
10. 496.715
11. 496.721
12. 496.722
13. 496.723
14. 496.724
15. 496.725
16. 496.780
The manufacturer received complaints that the fracture clamp could not be used with the affected screws because the shaft of the screws was manufactured out of specification (too thick). In the presence of one non-conforming Schanz Screw a surgical delay that is not clinically significant will most likely result; less than 5 minutes would be required to exchange the offending screw. However, there is the potential for more than one screw to be non-conforming. In this situation a surgical delay that is clinically significant could result; greater than 15 minutes may be required to exchange the offending screws or replace the Schanz Screw system with an alternative pedicle screw construct.
According to the manufacturer, the error was not detected, because the parts were measured above the tap and in the middle of the screw, but not at the end where the clamp is attached. This inspection method and the micrometer had been identified as inadequate for these products (496.724 / 496.723).
The local supplier will perform on-site checks and collect back the affected products and product replacement will be provided if needed.
According to the local supplier, the affected products were distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 14 June 2013