UNK
Received Dec 29, 2025 · Event occurred Dec 5, 2025
Report 1220246-2025-05844 · MDR key 23905482
Device
Generic name
Manual Instr, General Surgical
Manufacturer
Arthrex, Inc.Model number
UNKCatalog number
UNK
Lot number
UNK
Product problems
- Break
- Break
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: G3, H3, H6. BASED ON THE INFORMATION PROVIDED, WHICH MAY INCLUDE THE RETURNED DEVICE (IF AVAILABLE), PHOTOGRAPHS, VIDEOS, EVENT DESCRIPTION, AND ANY ADDITIONAL FIELD INPUT, ARTHREX HAS DETERMINED THE MOST LIKELY CAUSE. THE MOST LIKELY CAUSE OF THE REPORTED FAILURE IS USER-RELATED, SUCH AS EXCESSIVE FORCE DURING NEEDLE FIRING. DFU-0392-SUB-EO WARNS AGAINST THE LISTED USES TO HELP PREVENT NEEDLE BREAKAGE AND POTENTIAL PATIENT INJURY.
Additional Manufacturer Narrative
INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.
Description of Event or Problem
ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-12990 KNEE SCORPION HAD THE NEEDLE BREAK INSIDE THE CANNULA AND WAS UNABLE TO BE DISLODGED. THIS WAS DISCOVERED DURING A PROCEDURE WITH NO PATIENT HARM OR CASE DELAY REPORTED. ADDITIONAL INFORMATION PROVIDED 10-DEC-2025: IT WAS FURTHER REPORTED THIS OCCURRED DURING AN ACL WITH MEDICAL ROOT REPAIR PROCEDURE THAT WAS COMPLETED WITH ANOTHER KNEE SCORPION.