Transpedicular Schanz Screw 의 안전성 경고

Safety alert

2013-06-14

2013-06-14

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20130614a.html

Medical device safety alert: synthes transpedicular schanz screw 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.