ARTHREX
Received Oct 29, 2018 · Event occurred Oct 2, 2018
Report 3032391-2018-00014 · MDR key 8014751
Device
Generic name
Multifire Scorpion Needle (black) Or (dark Grey)
Manufacturer
Medline RenewalModel number
AR-13995NCatalog number
AR13995NR
Lot number
UNK
Product problems
- Break
- Detachment of Device or Device Component
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THAT THE REPROCESSED ARTHREX SCORPION NEEDLE'S TIP BROKE OFF INSIDE OF THE PATIENT DURING USE IN AN UNIDENTIFIED ORTHOPEDIC PROCEDURE. PER REPORT, THE BROKEN TIP WAS SUCCESSFULLY RETRIEVED FROM THE PATIENT THROUGH FLUSHING WITH SALINE. ANOTHER DEVICE WAS OPENED AND THE PROCEDURE CONTINUED WITHOUT FURTHER INCIDENT. THERE WAS NO REPORT OF PROLONGED ANESTHESIA, A SERIOUS INJURY OR AN ADVERSE PATIENT EVENT RELATED TO THE REPORTED INCIDENT. DUE TO THE REPORTED INCIDENT AND IN AN ABUNDANCE OF CAUTION, RENEWAL IS FILING THIS MEDWATCH. 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. IT CANNOT BE CONFIRMED IF THE DEVICE IS A REPROCESSED DEVICE. A ROOT CAUSE COULD NOT BE DETERMINED AT THIS TIME. NO ADDITIONAL INFORMATION IS AVAILABLE. IF ADDITIONAL 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. THE BROKEN TIP WAS SUCCESSFULLY REMOVED FROM THE PATIENT THROUGH FLUSHING WITH SALINE.