HEIGHT EXPANSION DRIVER
Received Dec 13, 2021 · Event occurred Nov 29, 2021
Report 3004774118-2021-00390 · MDR key 12987746
Device
Generic name
Spinal Vertebral Body Replacement Device
Manufacturer
K2m, Inc.Model number
2112-90007Catalog number
2112-90007
Lot number
ELDG
Product problems
- Material Deformation
- Material Deformation
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A CAPRI EXPANDABLE HEIGHT EXPANSION DRIVER "NO LONGER GRIPS THE SCREW HEAD" AFTER CLEANING/STERILIZATION. THERE IS NO PROCEDURE ASSOCIATED WITH THIS REPORTED EVENT, NO PATIENT INVOLVEMENT, AND NO ADVERSE CONSEQUENCE HAS BEEN REPORTED.
Description of Event or Problem
IT WAS REPORTED THAT A CAPRI EXPANDABLE HEIGHT EXPANSION DRIVER "NO LONGER GRIPS THE SCREW HEAD" AFTER CLEANING/STERILIZATION. THERE IS NO PROCEDURE ASSOCIATED WITH THIS REPORTED EVENT, NO PATIENT INVOLVEMENT, AND NO ADVERSE CONSEQUENCE HAS BEEN REPORTED.
Additional Manufacturer Narrative
VISUAL INSPECTION: THE TIP OF THE DRIVER WAS DEFORMED AND STRIPPED. DEVICE HISTORY RECORDS WERE REVIEWED FOR THIS LOT AND NO RELEVANT MANUFACTURING ISSUES WERE IDENTIFIED. COMPLAINT HISTORY RECORDS WERE REVIEWED FOR THIS LOT, SIMILAR COMPLAINTS WERE IDENTIFIED. FROM THE CAPRI SURGICAL TECHNIQUE GUIDE: THE LIFE OF THE INSTRUMENT DEPENDS ON THE NUMBER OF TIMES THEY ARE USED AS WELL AS THE PRECAUTIONS TAKEN IN HANDLING, CLEANING AND STORAGE. GREAT CARE MUST BE TAKEN OF THE INSTRUMENTS TO ENSURE THAT THEY REMAIN IN GOOD WORKING ORDER. INSTRUMENTS SHOULD BE EXAMINED FOR WEAR OR DAMAGE BY DOCTORS AND STAFF IN OPERATING CENTERS PRIOR TO SURGERY AS THE DEVICE IS FIVE YEARS OLD, WEAR FROM ITS EXTENDED USE IS THE LIKELY CAUSE FOR THE EVENT. MISALIGNMENT WITH THE MATING SCREW AND/OR EXCESSIVE FORCE APPLIED MAY ALSO CAUSE THE TIP TO DEFORM.