ERISMA LP
Received Mar 4, 2020 · Event occurred Aug 20, 2019
Report 3009962553-2019-00005 · MDR key 9786165
Device
Generic name
Screwdriver Shaft
Manufacturer
Clariance SasModel number
18911039Catalog number
18911039
Lot number
H224X
Product problems
- Material Fragmentation
- Material Fragmentation
Patient
72 YR
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
A FOLLOW-UP REPORT WILL BE FILED ONCE THE ANALYSIS IS PERFORMED.
Description of Event or Problem
THE SURGEON EXPERIENCED TWO BROKEN TIPS ON THE PEDICLE SCREW DRIVERS. ONE OF THE TIPS WAS BROKEN OFF IN THE SCREW AND DISPOSED OF WITH THE SCREW. THE TIP WAS RETRIEVED AND NOT LEFT IN THE PATIENT. THE SECOND DRIVER TIP WAS CRACKED, BUT NOT BROKEN OFF COMPLETELY. THE BROKEN DRIVER OCCURRED AT L5-S1 AND BOTH BREAKAGES WERE AT THE SAME PILOT HOLE. NO HARM OCCURRED TO THE PATIENT AND THE SURGERY COMPLETED WITHOUT FURTHER INCIDENT.
Additional Manufacturer Narrative
A FOLLOW-UP REPORT WILL BE FILED ONCE THE ANALYSIS IS PERFORMED. 12/20/2019 - AFTER ANALYSIS USING A MAGNIFYING GLASS, IT APPEARS A NET BREAK OF THE TIP OF THE SHAFT. MOREOVER, IT IS POSSIBLE TO NOTICE A STOP AT THE OPPOSITE OF THE BREAK POINT. ALL STRIATIONS ARE IN THE SAME DIRECTION. THIS BREAK IS CHARACTERISTIC OF OVER-BENDING BY THE SURGEON. - ATTACHMENT: [30RA23.PDF].
Description of Event or Problem
THE SURGEON EXPERIENCED TWO BROKEN TIPS ON THE PEDICLE SCREW DRIVERS. ONE OF THE TIPS WAS BROKEN OFF IN THE SCREW AND DISPOSED OF WITH THE SCREW. THE TIP WAS RETRIEVED AND NOT LEFT IN THE PATIENT. THE SECOND DRIVER TIP WAS CRACKED, BUT NOT BROKEN OFF COMPLETELY. THE BROKEN DRIVER OCCURRED AT L5-S1 AND BOTH BREAKAGES WERE AT THE SAME PILOT HOLE. NO HARM OCCURRED TO THE PATIENT AND THE SURGERY COMPLETED WITHOUT FURTHER INCIDENT.
Remedial action
- Replace