Arthrex® AR-12990NRecalls & reported problems

Summary

The FDA's MAUDE database contains 197 adverse event reports that list this exact device (DI 00888867199354), received between Jun 9, 2017 and Sep 15, 2026 — classified as 19 injuries, 178 malfunctions.

The most frequently reported specific device problem is “Break” (183 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 197 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Break

  On 27-Aug-2026, it was reported by a Sales Representative via SEMS-(b)(6) that an AR-12990N scorpion needle became jammed in the tip of the knee scorpion shaft after firing, and the tip of the scorpion needle broke off when removed from the scorpion. And an AR-1594D-24 drill and passing wire Stylets on the back of both pins broke when being screwed back in to clear bony debris. This occurred during use in a case with no patient effect.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50771175 ↗
• MalfunctionMay 11, 2026Break

  IT WAS REPORTED THAT DURING A MENISCAL REPAIR SURGERY A NEEDLE BROKE INSIDE THE SCORPION PLIER AND REMAIN LODGED INSIDE THE FORCEPS, WHICH PREVENTS NEW NEEDLES FROM BEING INSERTED AND, AS A RESULT, RENDERS THE DEVICE UNUSABLE. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25141955 ↗
• MalfunctionApr 27, 2026Break

  ON 11TH APRIL 2026, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT 2 UNITS OF AR-12990N, SCORPION¿ NEEDLE, KNEE, WERE BROKEN WHEN THE SURGEON TRIED VERY HARD TO PASS A SUTURE THROUGH THE MENISCUS ROOT. THE PATIENT'S KNEE WAS SUPER SMALL AND SUPER TIGHT. WHEN THE NEEDLE PASSED THROUGH THE MENISCUS ROOT, THE NEEDLE TIP HIT THE FEMUR BONE AND BROKE. THIS WAS DETECTED DURING A RIGHT KNEE MENISCUS ROOT REPAIR AND CENTRALISATION PROCEDURE ON (B)(6) 2026. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. ADDITIONAL INFORMATION RECEIVED ON 14TH APRIL 2026: HOWEVER, THE BROKEN PIECES WERE NOT RETRIEVED FROM THE PATIENT. AS IT FELL TO THE BACK OF THE KNEE, SURGEON DARE NOT ANYHOW POKE AS THERE'S VASCULAR BUNDLES.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 24999313 ↗
• MalfunctionApr 27, 2026Break

  ON 11TH APRIL 2026, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT 2 UNITS OF AR-12990N, SCORPION¿ NEEDLE, KNEE, WERE BROKEN WHEN THE SURGEON TRIED VERY HARD TO PASS A SUTURE THROUGH THE MENISCUS ROOT. THE PATIENT'S KNEE WAS SUPER SMALL AND SUPER TIGHT. WHEN THE NEEDLE PASSED THROUGH THE MENISCUS ROOT, THE NEEDLE TIP HIT THE FEMUR BONE AND BROKE. THIS WAS DETECTED DURING A RIGHT KNEE MENISCUS ROOT REPAIR AND CENTRALISATION PROCEDURE ON (B)(6) 2026. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. ADDITIONAL INFORMATION RECEIVED ON 14TH APRIL 2026: HOWEVER, THE BROKEN PIECES WERE NOT RETRIEVED FROM THE PATIENT. AS IT FELL TO THE BACK OF THE KNEE, SURGEON DARE NOT ANYHOW POKE AS THERE'S VASCULAR BUNDLES.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 24999217 ↗
• MalfunctionApr 8, 2026Break

  ON 16-MAR-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-12990N KNEE SCORPION NEEDLE TIP BROKE OFF DURING PASSAGE. THIS WAS DISCOVERED DURING A MENISCAL ROOT PROCEDURE WITH NO PATIENT HARM REPORTED. THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT AND THE CASE WAS COMPLETED WITH ANOTHER MANUFACTURER'S DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24816462 ↗
• MalfunctionApr 1, 2026Break

  ON (B)(6) 2026, AN ARTHREX EMPLOYEE REPORTED VIA EMAIL THAT THE AR-12990N SCORPION NEEDLE, KNEE BATCH 15386602 BECAME STUCK AND SUBSEQUENTLY BROKE INSIDE THE KNEE SCORPION SUTURE PASSER. THE ISSUE WAS IDENTIFIED DURING A QUADS ACL RECONSTRUCTION PROCEDURE. NO PIECE(S) BROKE OFF INSIDE THE PATIENT, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY MANUALLY STITCHING THE TENDON.

  Patient problems: Insufficient Information

  MAUDE report 24756087 ↗
• MalfunctionMar 16, 2026Break

  ON (B)(6), IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-(B)(4) THAT A QTY. 2 OF AR-12990N SCORPION NEEDLE TIPS BROKE. THIS WAS DISCOVERED DURING A PROCEDURE WITH NO PATIENT HARM. THE BROKEN PIECES WERE RETRIEVED PRIOR TO THE CLOSING OF CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24603869 ↗
• MalfunctionMar 13, 2026Break

  ON 20-FEB-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT A QTY. 2 OF AR-12990N SCORPION NEEDLE TIPS BROKE. THIS WAS DISCOVERED DURING A PROCEDURE WITH NO PATIENT HARM. THE BROKEN PIECES WERE RETRIEVED PRIOR TO THE CLOSING OF CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24595527 ↗
• MalfunctionMar 9, 2026Break

  ON 16-FEB-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-12990N SCORPION NEEDLE BROKE DURING CLOSURE FROM HARVESTING A QUAD TENDON. THERE WAS PROBABLY AN ADDITIONAL 30 MINUTES OF ANESTHESIA CONSIDERING WE HAD TO BRING IN FLUOROSCOPY TO CONFIRM THE NEEDLE WAS NOT LEFT INSIDE THE PATIENT. AS WELL AS PHYSICALLY ATTEMPTING TO FIND THE TIP WITHIN THE INCISION. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24544236 ↗
• MalfunctionMar 5, 2026Device Damaged by Another Device

  ON 13-FEB-2026, IT WAS REPORTED BY A DISTRIBUTOR VIA (B)(4) THAT A QTY. 7 OF AR-7250 FIBERWIRE #0, A QTY. 5 OF AR-7200 FIBERWIRE #2, A QTY. 1 OF AR-7535 FIBERLINK SUTURE TAPE WERE BEING CUT BY AN AR-12990N SCORPION NEEDLE DURING A MENISCAL ROOT REPAIR PROCEDURE. ANOTHER AR-12990N NEEDLE WAS OPENED BUT CONTINUED TO CUT THE SUTURES. AN AR-4068-90 SUTURE LASSO WAS THEN USED AS AN ALTERNATIVE TO TRY AND PASS THE SUTURES THROUGH TISSUE, BUT WAS ALSO UNSUCCESSFUL. THE CASE WAS COMPLETED SUCCESSFULLY WITH A SHOULDER SCORPION. NO PATIENT HARM WAS REPORTED, AND NO PIECES BROKE OFF INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24523748 ↗
• MalfunctionMar 5, 2026Device Damaged by Another Device

  ON (B)(6) 2026, IT WAS REPORTED BY A DISTRIBUTOR VIA (B)(4) THAT A QTY. 7 OF AR-7250 FIBERWIRE #0, A QTY. 5 OF AR-7200 FIBERWIRE #2, A QTY. 1 OF AR-7535 FIBERLINK SUTURE TAPE WERE BEING CUT BY AN AR-12990N SCORPION NEEDLE DURING A MENISCAL ROOT REPAIR PROCEDURE. ANOTHER AR-12990N NEEDLE WAS OPENED BUT CONTINUED TO CUT THE SUTURES. AN AR-4068-90 SUTURE LASSO WAS THEN USED AS AN ALTERNATIVE TO TRY AND PASS THE SUTURES THROUGH TISSUE BUT WAS ALSO UNSUCCESSFUL. THE CASE WAS COMPLETED SUCCESSFULLY WITH A SHOULDER SCORPION. NO PATIENT HARM WAS REPORTED, AND NO PIECES BROKE OFF INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24523704 ↗
• MalfunctionMar 5, 2026Break

  ON 13-FEB-2026, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT THE AR-12990N NEEDLE BROKE OFF AND IS STUCK IN THE SUTURE PASSER. THIS ISSUE WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24520749 ↗
• MalfunctionMar 2, 2026Break

  ON 12TH FEBRUARY 2026, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-12990, KNEE SCORPION¿, THE KNEE SCORPION NEEDLE SNAPPED INSIDE THE KNEE SCORPION AND JAMMED THE WHOLE DEVICE. THEY WERE UNABLE TO DISLODGE THE BROKEN NEEDLE FRAGMENT. THIS WAS DETECTED DURING A MENISCAL ROOT REPAIR PROCEDURE ON (B)(6) 2026. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS ANOTHER MENISCAL ROOT TRAY WAS OPENED AND THEY USED A DIFFERENT KNEE SCORPION AND NEEDLE.

  Patient problems: Insufficient Information

  MAUDE report 24484854 ↗
• MalfunctionFeb 23, 2026Break

  ON 05-FEB-2026, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT THE AR-12990N SCORPION NEEDLE BROKE OFF INSIDE A PATIENT AND WAS LEFT INSIDE THE PATIENT. THIS ISSUE WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.

  Patient problems: Foreign Body In Patient

  MAUDE report 24413833 ↗
• MalfunctionFeb 16, 2026Break

  IT WAS REPORTED THAT DURING THE MENISCAL ROOT REPAIR, THE NEEDLE BROKE WHEN IT WAS INSERTED THROUGH THE MENISCUS. PART OF THE BROKEN NEEDLE REMAINED IN THE MENISCUS. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE WAS USED ANYWAY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 24343853 ↗
• MalfunctionFeb 16, 2026Break

  ON 28-JAN-2026, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-12990N SCORPION NEEDLE TIP BROKE. IT WAS REPORTED THAT DURING A MENISCAL ROOT REPAIR SURGERY, A SCORPION HANDPIECE WAS USED, AND WHEN THE STITCH WAS PASSED THROUGH THE ROOT, THE TIP OF THE ROOT BROKE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24343244 ↗
• MalfunctionFeb 4, 2026Break

  ON (B)(6) 2026, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AR-12990N SCORPION NEEDLE, KNEE BATCH 15476962 NEEDLE TIP BROKE IN PATIENT'S KNEE DURING A PROCEDURE ON (B)(6) 2026. THIS WAS DETECTED WHEN THE ATTENDING REPRESENTATIVE ATTEMPTED TO LOAD THE SUTURE ONTO THE SCORPION NEEDLE ON (B)(6) 2026. THE FRAGMENT WAS REMOVED FROM THE PATIENT, AND THE ACL RECONSTRUCTION AND MENISCUS ROOT REPAIR WERE COMPLETED SUCCESSFULLY. NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24257161 ↗
• MalfunctionJan 26, 2026Break

  ON 12-JAN-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(6) THAT AN AR-12990 KNEE SCORPION NEEDLE BROKE OFF IN THE DEVICE AFTER THE THIRD TISSUE PASS. THIS WAS DISCOVERED DURING A QUAD ACL RECONSTRUCTION WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24178459 ↗
• MalfunctionJan 23, 2026Break

  IT WAS REPORTED THAT DURING THE REPAIR OF A RADIAL POSTERIOR MENISCUS TEAR, THE TIP OF THE NEEDLE BROKE OFF. THE BROKEN PIECE REMAINED IN THE PATIENT´S KNEE. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE (AR-4580). IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 24161562 ↗
• MalfunctionDec 18, 2025Break; Break

  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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23838656 ↗
• MalfunctionDec 17, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE TIP OF THE NEEDLE BROKE AND WAS STUCK 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23826887 ↗
• MalfunctionDec 10, 2025Break; Break

  IT WAS REPORTED THAT DURING A SURGERY THE INSTRUMENT AR-12990 (LOT: 15333400) WAS USED FOR THE FIRST TIME WITH A NEW AR-12990N NEEDLE, BUT DURING THE OPERATION THE NEEDLE IN THE INSTRUMENT BROKE. ALL FRAGMENTS WERE REMOVED, BUT THE INSTRUMENT DID NOT WORK. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. NO FURTHER INFORMATION RECEIVED. UPDATE AVOE 08-DEC-2025 IT WAS CONFIRMED THAT THE ERROR OCCURRED DURING A MENISCUS SUTURING INSIDE-OUT SURGERY. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE. IT WAS NOT NECESSARY TO DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23769823 ↗
• MalfunctionDec 8, 2025Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED ON 10-DEC-2025: THIS WAS DISCOVERED DURING A LEFT KNEE ARTHROSCOPY, MEDIAL MENISCUS ROOT REPAIR, AND RIGHT KNEE CORTISONE INJECTION PROCEDURE ON (B)(6) 2025. THE SURGERY WAS NOT DELAYED, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23745042 ↗
• MalfunctionDec 8, 2025Device Damaged by Another Device; Device Damaged by Another Device

  ON 11/19/2025, AN FDA MEDSUN NOTIFICATION WAS RECEIVED VIA EMAIL. A FACILITY REPRESENTATIVE REPORTED THAT AN AR-12990N KNEE SCORPION NEEDLE WAS LOADED, AND UPON DEPLOYMENT BY THE SURGEON, IT DID NOT DEPLOY AS INTENDED. AFTER REMOVAL, IT WAS DISCOVERED THAT THE NEEDLE HAD BROKEN OFF INSIDE THE CHANNEL OF THE INSTRUMENT PASSER. THE NEEDLE DID NOT ENTER THE PATIENT, AND THE BROKEN PIECE WAS RETRIEVED. THIS WAS DISCOVERED DURING A PROCEDURE IN (B)(6) OF 2025.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23744939 ↗
• MalfunctionDec 8, 2025Break; Break

  IT WAS REPORTED THAT WHILE IN USE THE NEEDLE AR-12990N (LOT: 15336337) SNAPPED INSIDE THE SCORPION DEVICE. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23743755 ↗