Arthrex® AR-1249Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10888867006161), received between Dec 16, 2016 and Nov 25, 2025 — classified as 4 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 25, 2025Break; Break

  ON 11/05/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-1249 NIT G-PIN. BIO-INTERF SCRW 1.1MM WIRE BROKE OFF AT THE END INSIDE THE PATIENT. THIS WAS PART OF AR-1898S DISPS KIT, TRANS-TIB ACL W/O SAWBLD. THIS WAS DISCOVERED DURING AN ACL RECONSTRUCTION. THE PIECE WAS REMOVED AND THE CASE WAS COMPLETED WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23645923 ↗
• InjuryMay 7, 2025Break; Break

  ON 04/09/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-1249 NITINOL GUIDE PIN FOR BIO-INTERFERENCE SCREWS BROKE. THIS WAS DISCOVERED A WEEK AFTER UNDERGOING AN ACL RECONSTRUCTION ON (B)(6) 2025. THE PATIENT WAS EXPERIENCING PAIN AND WENT IN FOR A FOLLOW-UP. AN X-RAY CONFIRMED THERE WAS A FRAGMENT IN THE PATIENT'S KNEE. THE REVISION PROCEDURE HAS TAKEN PLACE AND THE FRAGMENT WAS REMOVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 21979213 ↗
• MalfunctionSep 12, 2024Break; Break

  IT WAS REPORTED BY A SALES REPRESENTATIVE THAT AN AR-1249 NITINOL GUIDE PIN FOR BIO-INTERFERENCE SCREWS HAD A 2 INCH PIECE OF THE NITINOL GUIDEWIRE BREAK OFF IN THE PATIENT. THE CASE WAS COMPLETED WITHOUT FURTHER INFORMATION ON WHETHER THE BROKEN NITINOL GUIDEWIRE HAD BEEN RETRIEVED FROM THE PATIENT. THE REP WAS UNAWARE OF THIS EVENT IN THE CASE, THE CURRENT STATUS OF THE PATIENT, AND THE WHEREABOUTS OF THE NITINOL WIRE. THIS OCCURRED DURING AN ACL RECONSTRUCTION AND MENISCUS REPAIR PROCEDURE ON (B)(6) 2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20200851 ↗
• InjuryMar 30, 2023Break; Break

  ON 3/13/2023, IT WAS REPORTED BY A MEDWATCH LETTER VIA EMAIL THAT AN AR-1249 NITINOL GUIDE PIN FOR BIO-INTERFERENCE SCREWS BROKE IN THE PATIENT'S TIBIA DURING A LEFT KNEE ARTHROSCOPIC ASSISTED ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH PATELLAR TENDON AUTOGRAFT AND LATERAL MENISCUS REPAIR PROCEDURE ON (B)(6) 2022. THE BROKEN GUIDE PIN WAS DISCOVERED DURING A POSTOPERATIVE SCAN. A REVISION SURGERY TOOK PLACE TO REMOVE THE BROKEN FRAGMENT. NO FURTHER INFORMATION WAS REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16645657 ↗
• MalfunctionFeb 23, 2023Break

  IT WAS REPORTED THAT DURING A KNEE SURGERY THE PINS BROKE AT THE "LASER MARKING" END. 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 10-FEB-2023: IT WAS CONFIRMED THAT THE DEVICE BROKE INSIDE THE PATIENT AND ALL FRAGMENTS WERE REMOVED FROM THE PATIENT.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16427334 ↗
• MalfunctionFeb 20, 2023Break

  IT WAS REPORTED THAT DURING A KNEE SURGERY THE PINS BROKE AT THE LASER MARKING NEAR THE TIP. THE BROKEN PIECES WERE RETRIEVED OUT OF THE PATIENT. 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 16403641 ↗
• InjuryNov 15, 2018Break; Entrapment of Device

  IT WAS REPORTED VIA MEDWATCH REPORT (B)(4), THAT A (B)(6) FEMALE UNDERWENT A RIGHT KNEE ARTHROSCOPY WITH DEBRIDEMENT AND ALLOGRAFT BONE PATELLA TENDON BONE ACL RECONSTRUCTION. DURING THE PROCEDURE THE TIP OF THE GUIDEWIRE FROM THE ARTHREX ACL KIT BROKE AND BECAME EMBEDDED IN THE DISTAL FEMUR. SPECIFIC (B)(6) 2018 DATE OF PROCEDURE WAS NOT SHOWN ON MEDWATCH REPORT RECEIVED. (B)(6) 2018 HAS BEEN ENTERED AS THE PROCEDURE DATE. ADDITIONAL INFORMATION WILL BE REQUESTED. ADDITIONAL INFORMATION OBTAINED 10/30/2018: DATE OF PROCEDURE WAS (B)(6) 2018. FACILITY HAS DEVICE AND HAS AGREED TO RETURN FOR EVALUATION. ADDITIONAL INFORMATION OBTAINED 11/15/2018: SALES REP HAS CONFIRMED THAT THE CORRECT PART NUMBER FOR THE GUIDEWIRE IS AR-1249 (NOT AR-5025K AS WAS REPORTED BY THE FACILITY IN THE MEDWATCH). THIS GUIDEWIRE IS FROM AN AR-1987S KIT THAT WAS OPENED FOR THE PROCEDURE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8074625 ↗
• InjuryDec 16, 2016Material Fragmentation

  IT WAS REPORTED THAT AFTER THE ACL SURGERY, DURING THE CONTROL X-RAY, THE SURGEON FOUND A FRAGMENT OF THE PIN. HE DID A SECOND SURGERY THE SAME DAY TO REMOVE IT. NO MORE INFORMATION HAS BEEN MADE AVAILABLE BY THE CUSTOMER.

  Patient problems: No Code Available

  MAUDE report 6180339 ↗