Arthrex® AR-1915FTRecalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00888867022607), received between Jul 12, 2018 and Mar 23, 2026 — classified as 8 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Break” (26 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 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 23, 2026Break

  IT WAS REPORTED THAT DURING A FLATFOOT SURGERY THE HAND PIECE BROKE OFF DURING INSERTION OF THE ANCHOR. THE ANCHOR WAS PLACED SUCCESSFULLY AND REMAINED INSIDE THE PATIENT AS PLANNED. 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 24662481 ↗
• MalfunctionMar 23, 2026Break

  IT WAS REPORTED THAT DURING A FLATFOOT SURGERY THE HAND PIECE BROKE OFF DURING INSERTION OF THE ANCHOR. DUE TO THIS FAILURE ONE ANCHOR HAD TO BE REMOVED AND REPLACED WITH A NEW ONE. 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 24662477 ↗
• MalfunctionDec 17, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-1915FT CORKSCREW'S STITCHES WERE COMING OUT. THIS WAS DISCOVERED DURING USE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23830326 ↗
• MalfunctionDec 17, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA SEMS-07135668 THAT AN AR-1915FT CORKSCREW'S STITCHES WERE COMING OUT. THIS WAS DISCOVERED DURING USE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23830306 ↗
• MalfunctionDec 1, 2025Break; Break

  IT WAS REPORTED DURING THE SUTURE OF THE RADIAL COLLATERAL LIGAMENT THAT THE ANCHOR BROKE OFF WHEN IT WAS SCREWED INTO THE BONE. THE BROKEN PIECES WERE 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 23680120 ↗
• MalfunctionAug 13, 2025Break; Break

  ON 07/28/2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-1915FT SUTURE ANCHORS INSERTER BROKE OFF. THIS OCCURRED DURING A CASE, THEY SUSPECTED THE PATIENT HAD HARD BONE QUALITY AND DRILLED A HOLE THAT WAS A BIT LARGER USING A 2.7MM DRILL. A PORTION OF THE ANCHOR WAS HALF WAY IN AND REMAINS IN THE PATIENT. A LARGER HOLE WAS DRILLED USING A 3.0 MM DRILL AND AN ADDITIONAL AR-1915FT SUTURE ANCHOR WAS USED TO COMPLETE THE CASE. THERE WAS APPROXIMATELY A FIVE MINUTE DELAY IN WHICH IT IS UNCERTAIN IF ADDITIONAL ANESTHESIA WAS ADMINISTERED. THERE WAS NO HARM ON THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 22792310 ↗
• MalfunctionJul 30, 2025Break; Break

  ON 07/07/2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-1915FT SUTURE ANCHOR BROKE. THIS OCCURRED DURING A QUADRICIPITAL KNEE TENDON REPAIR. WHEN IT WAS PLACED, IT BROKE BEFORE IT WAS COMPLETELY IN PLACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22664950 ↗
• MalfunctionJul 15, 2025Break; Break

  IT WAS REPORTED THAT DURING A FOOT SURGERY WHILE THE SURGEON SCREWED DOWN THE ANCHOR WHEREUPON THE CHISEL ITSELF BREAKS OFF AT THE FRONT OF THE TOP. 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 DW 25-JUN-2025: FURTHER INFORMATION WAS PROVIDED THAT THE BROKEN PART WAS RETRIEVED OUT OF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22511834 ↗
• MalfunctionOct 2, 2024Break; Break

  IT WAS REPORTED THAT DURING A TENDON SUTURE SURGERY THE TIP OF THE DEVICE BROKE. THEREFORE, THE SUTURE COULD NOT BE INSERTED. 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 20354638 ↗
• MalfunctionSep 25, 2024Break; Break

  IT WAS REPORTED THAT DURING A LATERAL ANKLE LIGAMENT SURGERY THE TIP OF THE DEVICE BROKE OFF 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 20301762 ↗
• MalfunctionJun 28, 2024Break; Break

  IT WAS REPORTED THAT DURING A BICEPS TENDON REFIXATION SURGERY THE SCREWDRIVER HEADS OF THE DEVICES AR-1915FT (LOT: 15215886) BROKE OFF WITHOUT ANY PARTICULAR FORCE BEING APPLIED AND REMAINED IN THE ANCHOR. THIS HAPPENED WITH 3 OUT OF 4 ANCHORS (ALL FROM THE SAME PACK). 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: Insufficient Information

  MAUDE report 19632045 ↗
• MalfunctionJun 28, 2024Break; Break

  IT WAS REPORTED THAT DURING A BICEPS TENDON REFIXATION SURGERY THE SCREWDRIVER HEADS OF THE DEVICES AR-1915FT (LOT: 15215886) BROKE OFF WITHOUT ANY PARTICULAR FORCE BEING APPLIED AND REMAINED IN THE ANCHOR. THIS HAPPENED WITH 3 OUT OF 4 ANCHORS (ALL FROM THE SAME PACK). 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: Insufficient Information

  MAUDE report 19631798 ↗
• MalfunctionJun 28, 2024Break; Break

  IT WAS REPORTED THAT DURING A BICEPS TENDON REFIXATION SURGERY THE SCREWDRIVER HEADS OF THE DEVICES AR-1915FT (LOT: 15215886) BROKE OFF WITHOUT ANY PARTICULAR FORCE BEING APPLIED AND REMAINED IN THE ANCHOR. THIS HAPPENED WITH 3 OUT OF 4 ANCHORS (ALL FROM THE SAME PACK). 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: Insufficient Information

  MAUDE report 19631760 ↗
• MalfunctionApr 16, 2024Use of Device Problem; Use of Device Problem

  ON 4/12/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1915FT CORKSCREW FT SUTURE COULD NOT BE LOADED INTO ANCHOR. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2022. ADDITIONAL INFORMATION RECEIVED ON 4/15/2022: THIS WAS DISCOVERED DURING A LATERAL EPICONDYLECTOMY PROCEDURE ON (B)(6) 2022. AFTER THE CORKSCREW WAS IMPLANTED, THE DRIVER HANDLE WAS PULLED AWAY FROM THE ANCHOR, LEAVING THE ANCHOR IN THE BONE WITH NO SUTURE. ADDITIONAL INFORMATION RECEIVED ON 4/18/2022: SURGEON REMOVED THE ANCHOR AND INSERTED ANOTHER AR-1915FT CORKSCREW ANCHOR IN THE SAME BONE SOCKET. NO FURTHER ISSUES HAS BEEN REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 19117852 ↗
• MalfunctionJan 5, 2024Break; Break

  ON 12/11/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE THAT AN AR-1915FT CORKSCREW FT U-SHAPE PRONGS BROKE DURING INSERTION OF THE ANCHOR. THE PRONGS WERE STUCK IN THE ANCHOR; THE ANCHOR WAS FULLY SEATED. IT TOOK ABOUT 20 MINUTES TO REMOVE THE PRONGS, WHICH ENDED UP CUTTING THE SUTURES, MAKING THE ANCHOR UNUSABLE. THE CASE WAS COMPLETED USING AN AR-1928SF-45 CORKSCREW FT. ADDITIONAL ANESTHESIA WAS ADMINISTERED TO MAKE UP FOR THE TWENTY-MINUTE DELAY. THE PATIENT SUFFERED NO NEGATIVE EFFECTS ON OR AFTER THE PROCEDURE. THIS WAS DISCOVERED DURING A DELTOID REPAIR PROCEDURE ON (B)(6) 2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18458890 ↗
• MalfunctionJan 5, 2024Difficult to Insert; Difficult to Insert

  ON 12/11/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE THAT AN AR-1915FT CORKSCREW FT U-SHAPE PRONGS BROKE DURING INSERTION OF THE ANCHOR. THE PRONGS WERE STUCK IN THE ANCHOR; THE ANCHOR WAS FULLY SEATED. IT TOOK ABOUT 20 MINUTES TO REMOVE THE PRONGS, WHICH ENDED UP CUTTING THE SUTURES, MAKING THE ANCHOR UNUSABLE. THE CASE WAS COMPLETED USING AN AR-1928SF-45 CORKSCREW FT. ADDITIONAL ANESTHESIA WAS ADMINISTERED TO MAKE UP FOR THE TWENTY-MINUTE DELAY. THE PATIENT SUFFERED NO NEGATIVE EFFECTS ON OR AFTER THE PROCEDURE. THIS WAS DISCOVERED DURING A BROSTROM REPAIR PROCEDURE ON (B)(6) 2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18458754 ↗
• MalfunctionDec 28, 2023Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1915FT CORKSCREW FT U-SHAPE PRONGS BROKE DURING INSERTION OF THE ANCHOR. ALL BROKEN FRAGMENTS WERE REMOVED FROM INSIDE THE PATIENT AND THE CASE WAS COMPLETED SUCCESSFULLY. THIS WAS DISCOVERED DURING A BROSTROM PROCEDURE ON (B)(6) 2023. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2023: THE CASE WAS COMPLETED USING A NEW AR-1915FT CORKSCREW FT. PLIERS WERE USED TO TURN THE CORKSCREW IN REVERSE AND REMOVE IT. ADDITIONAL ANESTHESIA WAS ADMINISTERED TO MAKE UP FOR THE TEN-MINUTE DELAY. THE PATIENT SUFFERED NO NEGATIVE EFFECTS ON OR AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18415374 ↗
• InjurySep 27, 2023Break; Break

  ON 8/30/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1915FT CORKSCREW FT INSERTER TIP BROKE AND AMPUTATED THE SUTURES WHEN SLIDING THEM TO MAKE SURE THEY WERE MOBILE. THE SURGEON USED TWO MORE AR-1915FT CORKSCREW FT, AND THE INSERTER TIP ALSO BROKE. THE SURGEON USED A SCREW REMOVAL SET TO RETRIEVE THE BROKEN FRAGMENTS. THIS WAS DISCOVERED DURING AN ANKLE DELTOID REPAIR PROCEDURE ON (B)(6) 2023. ADDITIONAL INFORMATION RECEIVED ON 8/30/2023: THE CASE WAS COMPLETED BY REMOVING THE ANCHOR AND USING A SUTURE TO SOW THE TISSUE TOGETHER. THE CASE WAS DELAYED 60 MINUTES BECAUSE THE SURGEON WAS TRYING TO FIGURE OUT HOW TO REMOVE THE ANCHOR. ADDITIONAL INFORMATION RECEIVED ON 9/8/2023: THE SALES REPRESENTATIVE DOES NOT KNOW IF ADDITIONAL ANESTHESIA WAS ADMINISTERED DUE TO CASE DELAY.

  Patient problems: Insufficient Information

  MAUDE report 17827313 ↗
• MalfunctionJul 24, 2023Break; Break

  ON 06/27/2023, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA PHONE THAT AN AR-1915FT SUTURE ANCHOR CORKSCREW TIP BROKE OFF BEFORE THE ANCHOR WAS FULLY SEATED. THIS WAS DISCOVERED DURING A CASE, DEVICE BROKE DURING USE, ALL FRAGMENTS REMOVED.

  Patient problems: Insufficient Information

  MAUDE report 17378954 ↗
• MalfunctionApr 28, 2023Break; Break

  ON 3/29/2023, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-1915FT CORKSCREW FT SUTURE BROKE DURING IMPLANTATION. THE TIP OF THE INSERTER SHAFT WAS ALSO FOUND BROKEN. THE SURGEON REMOVED THE ANCHOR USING ANOTHER SCREWDRIVER. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2023. ADDITIONAL INFORMATION REQUESTED.

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

  MAUDE report 16837513 ↗
• MalfunctionDec 27, 2022Break

  IT WAS REPORTED THAT DURING A BICEPS TENDON SURGERY THE THREAD OF TWO ANCHORS BROKE OFF INSIDE THE PATIENT AT THE FRONT PART OF THE ANCHOR, SO THAT THEY COULD NO LONGER BE USED. WHEN IT WAS CHANGED TO ANOTHER BATCH, THE PROBLEM NO LONGER OCCURRED. THE BROKEN PIECES WERE RETRIEVED FROM PATIENT. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body In Patient

  MAUDE report 16051793 ↗
• MalfunctionSep 12, 2022Break

  IT WAS REPORTED THAT DURING A TRICEPS TENDON REPAIR SURGERY TWO ANCHORS OF THE SAME BATCH BROKE INTRAOPERATIVELY. ALL BROKEN PARTS WERE RETRIEVED FROM THE PATIENT. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. 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 15401810 ↗
• MalfunctionApr 26, 2021Break

  IT WAS REPORTED THAT DURING A LIGAMENT FOOT SURGERY ANCHOR AR-1915FT BROKE OFF INSIDE THE PATIENT. THE SURGEON REPORTED THAT 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 12-APR-2021: FURTHER INFORMATION WERE PROVIDED THAT THE DEVICE BROKE OFF INSIDE PIECE WAS RETRIEVED OUT OF THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 11725139 ↗
• MalfunctionFeb 9, 2021Use of Device Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN KNEE ARTHROSCOPIC PROCEDURE, THE SURGEON USED THE AR-1595FT ANCHOR, WHICH FIRST IMPACTED THE INDICATOR PIN AND THEN THE SURGEON PROCEEDED TO PLACE THE ANCHOR AR-1915FT, IN WHICH THE THREAD PASSES BUT A PORTION OF THE ANCHOR HANDLE SPLIT CAUSING THE DEVICE TO DISASSEMBLE. ALL FRAGMENTS WERE REMOVED AND THE CASE WAS COMPLETED BY USING ANOTHER AR-1915FT. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11301180 ↗
• MalfunctionFeb 9, 2021Break; Material Separation

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC AND LIGAMENT REPAIR, WHEN THE SURGEON PLACED THE ANCHOR, AR-1915FT, ON THE LAST TURN, A PORTION OF THE ANCHOR HANDLE SPLIT. IN ADDITION TO THE SPLIT HANDLE THE SUTURE BROKE WHEN KNOTTING. ALL FRAGMENTS WERE REMOVED AND THE CASE WAS COMPLETED BY USING ANOTHER AR-1915FT. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11301163 ↗