UNK
Received Jan 15, 2026 · Event occurred Dec 18, 2025
Report 1220246-2026-00231 · MDR key 24087000
Device
Product problems
- Break
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.
Description of Event or Problem
IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SURGERY THE NEEDLE BROKE INSIDE THE SCORPION. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: D9, G3, H3, H6. A FUNCTIONAL TEST OF THE RECEIVED AR-12990 WITH BATCH: 15245547 WITH A NEEDLE (AR-12990N-1 WITH BATCH: 15425015) REVEALED THAT NO FRAGMENT OF THE NEEDLE WAS STUCK INSIDE. IT WAS POSSIBLE TO FIRE THE NEEDLE (SEE EVALUATION PICTURES 1 + 2). REMAINING PARTS OF THE NEEDLE HAVE NOT BEEN RECEIVED. THEREFORE, THE REPORTED EVENT WAS NOT CONFIRMED.