MEDARTIS 1.0MMX20MM, L76MM, A0 FIXATION
Received Jun 13, 2022 · Event occurred Mar 29, 2022
Report 3003236702-2022-00001 · MDR key 14681377
Device
Product problems
- Break
- Entrapment of Device
- Use of Device Problem
- Break
- Entrapment of Device
- Use of Device Problem
Patient
50 YR · Male
- Device Embedded In Tissue or Plaque
- Device Embedded In Tissue or Plaque
Narrative
Description of Event or Problem
DURING AN UNKNOWN PROCEDURE ON THE METATARSAL BONE OF THE FOOT, WHILE PLACING ONE OF THE DISTAL SCREWS THE 1 MM DRILL BIT BROKE OFF IN THE SOFT TISSUE. THE PHYSICIAN WAS UNABLE TO EASILY REMOVE THE BROKEN BIT FROM THE METATARSAL WITHOUT CAUSING SIGNIFICANT FURTHER DAMAGE. THE PHYSICIAN OPTED TO LEAVE THE DRILL BIT TO AVOID FURTHER DAMAGE.
Additional Manufacturer Narrative
ON (B)(6) 2022, THE DEVICE MANUFACTURER (MEDARTIS AG) RECIEVED A FOI LETTER FROM FDA DIRECTLY. A FORMAL COMPLAINT INVESTIGATION BEGAN IMMEDIATELY FOLLOWING. BASED ON THE ADDITIONAL INFORMATION GATHERED FROM THE SUBSEQUENT COMPLAINT INVESTIGATION, THE PLATE USED WAS PART OF THE 1.2/1.5 HAND SYSTEM AND IS NOT INTENDED TO BE USED ON THE FOOT. BECAUSE THE SYSTEM IS INTENDED FOR USE IN THE BONES OF THE HAND, THE FORCE EXTERTED ON ON THE DRILL BIT WAS TOO HIGH. FOOT SYSTEMS SCREWS ARE LARGER AND CAN HANDLE THE ADDITIONAL FORCE WHEN USED AS INTENDED. THEREFORE, THE BREAKAGE OCCURRED DUE TO A MISUSE OF THE MATERIAL IN THE METATARSAL OF THE FOOT.