ARTHREX
Received Nov 16, 2018 · Event occurred Nov 9, 2018
Report 3032391-2018-00019 · MDR key 8079609
Device
Generic name
Multifire Scorpion Needle (black) Or (dark Grey)
Manufacturer
Medline RenewalCatalog number
AR13995NR
Lot number
UNK
Product problems
- Break
- Detachment of Device or Device Component
Patient
Not reported
- Device Embedded In Tissue or Plaque
- Device Embedded In Tissue or Plaque
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THAT THE REPROCESSED ARTHREX SCORPION NEEDLE'S TIP BROKE OFF INSIDE OF THE PATIENT DURING AN UNIDENTIFIED ORTHOPEDIC PROCEDURE. PER REPORT, A 6 MM PIECE/DEVICE FRAGMENT WAS OBSERVED ON THE X-RAY OF THE PATIENT'S SHOULDER. THERE WAS NO INFORMATION REPORTED WHETHER THE DEVICE FRAGMENT WAS RETRIEVED FROM THE PATIENT. THERE WAS NO REPORT OF PROLONGED ANESTHESIA, A SERIOUS INJURY OR ANOTHER ADVERSE PATIENT EVENT AT THIS TIME. DUE TO THE REPORTED INCIDENT AND IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. THE SAMPLE IS NOT AVAILABLE TO BE RETURNED FOR EVALUATION. THE LOT NUMBER ASSOCIATED WITH THE DEVICE WAS NOT REPORTED. A REVIEW OF THE REPROCESSING RECORD COULD NOT BE PERFORMED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE FILED.
Description of Event or Problem
IT WAS REPORTED THAT THE REPROCESSED ARTHREX SCORPION NEEDLE'S TIP BROKE OFF INSIDE OF THE PATIENT.