ERISMA LP
Received Oct 4, 2019 · Event occurred Jul 17, 2017
Report 3009962553-2019-00003 · MDR key 9157930
Device
Product problems
- Material Fragmentation
- Material Fragmentation
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE BREAKAGE OF THE QUICK-CONNECT ROD WAS CAUSED BY AN INCORRECT ASSEMBLY OF THE SCREWDRIVER BEFORE USE. WHEN THE SCREWDRIVER SHAFT IS NOT PROPERLY ENGAGED IN THE QUICK-CONNECT ROD, THIS CAUSES THE BREAKAGE OF THE STRIPS BY INTERFERING WITH THE WINDOW OF THE SCREWDRIVER TUBE.
Description of Event or Problem
THE SURGEON INITIALLY IMPLANTED A 7.5MM DIAMETER POLYAXIAL SCREW AND WAS UNABLE TO RELEASE THE LOCKING MECHANISM OF THE SCREWDRIVER. AS A CONSEQUENCE, THE SURGEON REMOVED THE POLYAXIAL SCREW INITIALLY IMPLANTED. HE USED ANOTHER SCREWDRIVER READILY AVAILABLE IN THE SET AND REPLACED THE 7.5MM DIAMETER POLYAXIAL SCREW WITH A 8.5MM DIAMETER POLYAXIAL SCREW. NO PATIENT HARM WAS REPORTED AND THE SURGERY WAS COMPLETED WITH NO FURTHER COMPLICATIONS.
Remedial action
- Replace