InjuryNKB
ERISMA LP
Received Nov 7, 2019 · Event occurred Sep 20, 2019
Report 3008992889-2019-00002 · MDR key 9291175
Device
Generic name
Screwdriver
Manufacturer
Clariance SasModel number
18911039Catalog number
18911039
Lot number
H224X
Product problems
- Material Fragmentation
Patient
Not reported
- Device Embedded In Tissue or Plaque
- Device Embedded In Tissue or Plaque
Narrative
Additional Manufacturer Narrative
FOR THIS ADVERSE EVENT, AS THE INCRIMINATED DEVICE HAS NOT BEEN RECEIVED YET, CLARIANCE (B)(4) IS UNABLE TO DO ANY ANALYSIS FOR THE MOMENT. NO ADDITIONAL INFORMATION ARE AVAILABLE. CLARIANCE WILL GO FORWARD ON THE INVESTIGATION WHEN THE INSTRUMENT IS RECEIVED.
Description of Event or Problem
SCREWDRIVER TIP BROKE OFF INSIDE THE SCREW HEAD. SHEARED OFF CLEANLY SO SURGEON LEFT THE SHEARED FRAGMENT IN PLACE AND LOCKED ROD DOWN OVERTOP OF IT.
Remedial action
- Replace