Arthrex® AR-12990N-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 00888867266520), received between Jan 10, 2018 and Aug 11, 2026 — classified as 2 injuries, 38 malfunctions.

The most frequently reported specific device problem is “Break” (34 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 40 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 11, 2026Break

  Patient problems: Foreign Body In Patient

  MAUDE report 50208320 ↗
• MalfunctionApr 13, 2026Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY IT WAS FOUND THAT THE NEEDLE IS NOT SUITABLE FOR USE. 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. UPDATE 07-APR-2026: FURTHER INFORMATION WAS PROVIDED THAT THE ATTEMPT TO SUTURE THE MENISCUS, THE NEEDLE BECAME BENT AND COULD NOT BE REUSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24862828 ↗
• MalfunctionApr 13, 2026Break

  IT WAS REPORTED THAT DURING A FIBERRING SURGERY THE SCORPION NEEDLE BROKE INSIDE THE KNEE 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 24859126 ↗
• MalfunctionMar 3, 2026Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY DURING MENISCUS SUTURING, THE TIP OF THE NEEDLE BROKE. NO FRAGMENT REMAINED INSIDE THE PATIENT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE (FIBERSTICH). IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24496043 ↗
• MalfunctionFeb 27, 2026Break

  IT WAS REPORTED THAT DURING THE REFIXATION OF THE POSTERIOR CRUCIATE LIGAMENT, THE NEEDLE BROKE WHILE FIRING WITH THE KNEE SCORPION. THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT. 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 24470686 ↗
• MalfunctionNov 5, 2025Break; Break

  IT WAS REPORTED THAT DURING A MENISCAL ROOT REPAIR SURGERY THE NEEDLE BROKE INSIDE THE SHAFT OF 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 23477803 ↗
• MalfunctionAug 7, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY THE NEEDLE WAS DEFECTIVE. 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. UPDATE AVOE 22-JUL-2025 IT WAS CONFIRMED THAT WHEN THE SCORPION WAS TRIGGERED, THE NEEDLE WAS UNABLE TO PENETRATE THE MENISCUS. AS A RESULT, THE NEEDLE BENT INSIDE THE DEVICE, ULTIMATELY LEADING TO A MATERIAL FRACTURE IN THE LUMEN OF THE SCORPION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22742562 ↗
• MalfunctionMay 23, 2025Break; Break

  ON 8TH MAY 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-12990 KNEE SCORPION, THE KNEE SCORPION NEEDLE BROKE OFF IN THE PATIENT. THIS WAS DETECTED DURING A REVISION ACL PROCEDURE ON (B)(6) 2025. THEY TRIED TO LOAD ANOTHER NEEDLE BUT DEVICE WAS BLOCKED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A NON-ARTHREX DEVICE. ON (B)(6) 2025 - THE ARTHREX EMPLOYEE CONFIRMED THAT THE BROKEN AR-12990N-1, SCORPION¿ NEEDLE, KNEE WAS STUCK IN THE AR-12990 KNEE SCORPION.

  Patient problems: Insufficient Information

  MAUDE report 22078542 ↗
• MalfunctionMay 15, 2025Break; Break

  ON (B)(6) 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-12990, KNEE SCORPION AND AR-12990N-1, SCORPION¿ NEEDLE, KNEE, THE TIP OF NEEDLE BROKE OFF WHILE USING KNEE SCORPION. THE NEEDLE WAS FAULTY. TIP OF NEEDLE WAS JAMMED INSIDE SCORPION AND IT WAS UNABLE TO BE USED. THIS WAS DETECTED DURING USE IN A MENISCAL ROOT REPAIR PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS STERILE SMITH & NEPHEW MINI FIRST PASS WAS USED.

  Patient problems: Insufficient Information

  MAUDE report 22026845 ↗
• MalfunctionMay 13, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE NEELDE BROKE. 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 22008665 ↗
• MalfunctionMay 9, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE NEEDLE AR-12990N-1 (LOT: 15320194) BROKE IN THE TOOL AR-12990 (LOT: 15240934) ON THE FIRST ATTEMPT TO USE IT. 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 21996545 ↗
• MalfunctionMay 5, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN ACL SURGERY THE NEEDLE BENT DURING INSERTION. 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 21963184 ↗
• MalfunctionApr 4, 2025Break; Break

  IT WAS REPORTED THAT DURING A MENISCAL REPAIR SURGERY THE NEEDLE WAS STUCK IN THE SCORPION. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21777754 ↗
• MalfunctionFeb 18, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ACL SURGERY THE NEEDLE BROKE AND WAS STUCK IN 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 21400440 ↗
• MalfunctionFeb 5, 2025Break; Break

  IT WAS REPORTED THAT DURING A ROOT REPAIR SURGERY THE NEEDLE BROKE INSIDE THE SCORPION. THE BROKEN PIECE WAS RETRIEVED OUT OF THE PATIENT. 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 SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21314328 ↗
• MalfunctionJan 30, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC KNEE 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 ANOTHER DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21275390 ↗
• MalfunctionJan 28, 2025Break; Break

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21253396 ↗
• MalfunctionJan 15, 2025Break; Break

  IT WAS REPORTED THAT DURING A CRUCIATE LIGAMENT SURGERY THE INSTRUMENT OF THE SCORPION NEEDLE KNEE HAS BEEN USED WHEN TWO NEEDLES BROKE OFF AND GOT STUCK AT THE INSTRUMENT. 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 21158962 ↗
• MalfunctionJan 15, 2025Break; Break

  IT WAS REPORTED THAT DURING A CRUCIATE LIGAMENT SURGERY THE INSTRUMENT OF THE SCORPION NEEDLE KNEE HAS BEEN USED WHEN TWO NEEDLES BROKE OFF AND GOT STUCK AT THE INSTRUMENT. 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 21158167 ↗
• MalfunctionJan 6, 2025Break; Break

  IT WAS REPORTED THAT DURING A TRANSOSSEOUS ROOT SUTURE THE NEEDLE BROKE IN THE SCORPION. THE BROKEN PART WAS STUCK IN 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 21079360 ↗
• MalfunctionNov 5, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SUTURING OF THE MENISCUS SURGERY WHEN INSERTING THE SUTURE, THE PUNCTURE NEEDLE BROKE. ALL FRAGMENTS WERE REMOVED FROM THE PATIENT. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE (FIBERSTITCH). IT WAS NOT NECESSARY TO DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20613341 ↗
• MalfunctionJul 25, 2024Break; Break

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY IT WAS NOTICED THAT THE NEEDLE IS BROKEN OFF INSIDE THE KNEE SCORPION. 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 19828947 ↗
• MalfunctionJul 11, 2024Break; Break

  IT WAS REPORTED THAT DURING A KNEE SURGERY IT WAS FOUND THAT THE SCORPION WAS BLOCKED AS PRIOR TO THIS EVENT A NEEDLE BROKE OFF AND REMAINED STUCK INSIDE THE DEVICE. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. 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. UPDATE 26-JUN-2024 DW: FURTHER INFORMATION WERE PROVIDED THAT THE NEEDLE BROKE DURING THE SAME SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19722311 ↗
• MalfunctionMay 20, 2024Break; Break

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY THE NEEDLE BROKE INSIDE THE KNEE SCORPION. ACCORDING TO THE SURGEON THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. 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 19352465 ↗
• MalfunctionApr 26, 2024Break; Break

  ON 4TH APRIL 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-12990N-1, SCORPION NEEDLE, KNEE BROKE WHEN PASSING THROUGH THE MENISCAL ROOT. THIS WAS DETECTED ON (B)(6) 2024 DURING USE IN A MENISCAL ROOT REPAIR PROCEDURE. PROCEDURE WAS COMPLETED SUCCESSFULLY AS ANOTHER NEEDLE WAS USED.

  Patient problems: Insufficient Information

  MAUDE report 19196133 ↗