SCORPION NEEDLE, KNEE
Received Dec 18, 2025 · Event occurred Oct 15, 2025
Report 1220246-2025-05684 · MDR key 23838656
Device
Generic name
Manual Instr, General Surgical
Manufacturer
Arthrex, Inc.Model number
SCORPION NEEDLE, KNEECatalog number
AR-12990N
Lot number
15476962
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
ADDITIONAL INFORMATION: B5, G3.
Description of Event or Problem
ADDITIONAL INFORMATION WAS RECEIVED ON 12/19/2025 FROM THE SALES REPRESENTATIVE PRESENT AT THE PROCEDURE: THIS OCCURRED DURING A QUADRICEPS TENDON ACL RECONSTRUCTION; THE TIP OF AN AR-12990N SCORPION NEEDLE BROKE WHILE CLOSING THE QUAD TENDON DEFECT. THE DETACHED FRAGMENT WAS LOCATED OUTSIDE THE PATIENT BY THE SURGICAL TECHNICIAN. THE BROKEN TIP AND REMAINING SHAFT WERE COMPARED TO AN INTACT NEEDLE, CONFIRMING THAT ALL COMPONENTS WERE ACCOUNTED FOR AND REMOVED FROM THE SURGICAL FIELD. THE PROCEDURE WAS COMPLETED USING A NON-ARTHREX PRODUCT. THE CASE EXPERIENCED AN APPROXIMATE FIVE-MINUTE DELAY; NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. NO ADVERSE PATIENT EFFECTS WERE REPORTED DURING OR AFTER SURGERY. ADDITIONAL INFORMATION WAS RECEIVED ON 12/24/2025: THE AR-12990 KNEE SCORPION WAS USED WITH THE AR-12990N SCORPION NEEDLE DURING THIS EVENT.
Description of Event or Problem
ON 11/26/2025, AN FDA MEDSUN NOTIFICATION WAS RECEIVED VIA EMAIL. A FACILITY REPRESENTATIVE REPORTED THAT THE TIP OF THE NEEDLE FROM AN AR-12990N SCORPION NEEDLE BROKE DURING A PROCEDURE PERFORMED IN (B)(6) 2025. THE BROKEN PIECE WAS RETRIEVED, AND NO X-RAY WAS REQUIRED, ACCORDING TO THE ATTENDING PHYSICIAN. ADDITIONAL INFORMATION WAS RECEIVED ON 12/05/2025: THIS OCCURRED ON (B)(6) 2025 DURING A PROCEDURE, AND NO PATIENT HARM WAS REPORTED.
Additional Manufacturer Narrative
INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.