Arthrex® AR-1915FT-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00888867022614), received between May 7, 2019 and Mar 23, 2026 — classified as 1 injury, 23 malfunctions.

The most frequently reported specific device problem is “Break” (21 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 16, 2026.

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 23, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A TENDON REFIXATION SURGERY THE SUTURES TORE AFTER THE ANCHOR WAS ALREADY INSERTED. THE ANCHOR REMAINED IN THE PATIENT'S BONE. 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: Foreign Body In Patient

  MAUDE report 24666623 ↗
• MalfunctionJan 8, 2026Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SURGERY THE ANCHOR BROKE WHILE IT WAS SCREWED IN. THE BROKEN PIECES WERE 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 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 24003293 ↗
• MalfunctionJun 13, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY THE IMPLANT FELL OUT OF THE PREPARED PLACE IN THE BONE. 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 22202558 ↗
• MalfunctionJun 13, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY THE IMPLANT FELL OUT OF THE PREPARED PLACE IN THE BONE. 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 22202400 ↗
• MalfunctionFeb 5, 2025Break; Break

  IT WAS REPORTED THAT DURING A LATERAL ANKLE RECONSTRUCTION SURGERY THE CORKSCREW ANCHORS AR-1915FT-1 (LOT: 2X 15241985 & 15157689) BROKE DURING INTRODUCTION. THIS HAPPENED 3 TIMES IN A ROW. THE CONNECTION BETWEEN THE INSERTER AND THE ANCHOR BROKE. BECAUSE OF THIS THE ANCHORS COULD NOT BE INSERTED DEEP ENOUGH AND HAD TO BE REMOVED. ALL FRAGMENTS WERE REMOVED FROM THE PATIENT. ONE OF THE ANCHORS HAD TO BE OVERDRILLED, RESULTING IN A BONE DEFECT WITH THE PATIENT. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE (BIG INTERFERENCE SCREW HAD TO USED). IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

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

  MAUDE report 21313820 ↗
• MalfunctionFeb 5, 2025Break; Break

  IT WAS REPORTED THAT DURING A LATERAL ANKLE RECONSTRUCTION SURGERY THE CORCKSREW ANCHORS AR-1915FT-1 (LOT: 2X 15241985 & 15157689) BROKE DURING INTRODUCTION. THIS HAPPENED 3 TIMES IN A ROW. THE CONNECTION BETWEEN THE INSERTER AND THE ANCHOR BROKE. BECAUSE OF THIS THE ANCHORS COULD NOT BE INSERTED DEEP ENOUGH AND HAD TO BE REMOVED. ALL FRAGMENTS WERE REMOVED FROM THE PATIENT. ONE OF THE ANCHORS HAD TO BE OVERDRILLED, RESULTING IN A BONE DEFECT WITH THE PATIENT. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE (BIG INTERFERENCE SCREW HAD TO USED). IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21313814 ↗
• MalfunctionFeb 5, 2025Break; Break

  IT WAS REPORTED THAT DURING A LATERAL ANKLE RECONSTRUCTION SURGERY THE CORCKSREW ANCHORS AR-1915FT-1 (LOT: 2X 15241985 & 15157689) BROKE DURING INTRODUCTION. THIS HAPPENED 3 TIMES IN A ROW. THE CONNECTION BETWEEN THE INSERTER AND THE ANCHOR BROKE. BECAUSE OF THIS THE ANCHORS COULD NOT BE INSERTED DEEP ENOUGH AND HAD TO BE REMOVED. ALL FRAGMENTS WERE REMOVED FROM THE PATIENT. ONE OF THE ANCHORS HAD TO BE OVERDRILLED, RESULTING IN A BONE DEFFECT WITH THE PATIENT. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE (BIG INTERFERENCE SCREW HAD TO USED). IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

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

  MAUDE report 21313810 ↗
• MalfunctionJan 28, 2025Break; Break

  IT WAS REPORTED THAT DURING A HANDWRIST SURGERY WHILE INSERTING THE ANCHOR IT BROKE. THE BROKEN OFF PIECE HAS BEEN 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 21252727 ↗
• MalfunctionDec 27, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ACHILLE SURGERY WHILE TRYING THE TIGHTENING AND PULL THE KNOT, THE ANCHORS 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 21025863 ↗
• MalfunctionDec 27, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ACHILLE SURGERY WHILE TRYING THE TIGHTENING AND PULL THE KNOT, THE ANCHORS 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 21025833 ↗
• MalfunctionDec 27, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ACHILLE SURGERY WHILE TRYING THE TIGHTENING AND PULL THE KNOT, THE ANCHORS 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 21025768 ↗
• MalfunctionNov 26, 2024Break; Break

  IT WAS REPORTED THAT DURING AN EXTERNAL LIGAMENT SURGERY ON THE FOOT THE ANCHOR OF THE SECOND DEVICE BROKE. THE BROKEN PARTS COULD BE RETRIEVED. 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 20780459 ↗
• MalfunctionNov 25, 2024Break; Break

  IT WAS REPORTED THAT DURING AN EXTERNAL LIGAMENT SURGERY ON THE FOOT THE ANCHOR OF THE FIRST DEVICE BROKE AND REMAINED IN 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: Foreign Body In Patient; Insufficient Information

  MAUDE report 20773393 ↗
• MalfunctionSep 13, 2024Break; Break

  IT WAS REPORTED THAT DURING A FOOT ARTHROSCOPY THE ANCHORAGE OF THE DEVICES AR-1915FT-1 (15221722 & 15222233) BROKE BEFORE THE DEVICES WERE DEEP ENOUGH IN THE TISSUE, ALTHOUGH THE SURGEON DRILLED 2-3 TIMES THE LENGTH REQUIRED FOR THE ANCHORS. THE ANCHORS WERE USED TO FINISH THE PROCEDURE. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICES. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20216987 ↗
• MalfunctionSep 13, 2024Break; Break

  IT WAS REPORTED THAT DURING A FOOT ARTHROSCOPY THE ANCHORAGE OF THE DEVICE BROKE BEFORE THE DEVICE WAS DEEP ENOUGH IN THE TISSUE, ALTHOUGH THE SURGEON DRILLED 2-3 TIMES THE LENGTH REQUIRED FOR THE ANCHOR. THE ANCHOR WAS USED TO FINISH THE PROCEDURE. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME 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 20216856 ↗
• MalfunctionSep 6, 2024Break; Break

  IT WAS REPORTED THAT DURING A BICEPS SURGERY THE SCREW BROKE DURING INSERTION. 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 20157128 ↗
• MalfunctionJun 21, 2024Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SLIL RECONSTRUCTION SURGERY THE IMPLANT BROKE WHILE BEING SCREWED INTO A PRE-DRILLED HOLE, CAUSING THE SUTURE BREAKAGE. THE BROKEN PIECES REMAINS INSIDE THE 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19589055 ↗
• MalfunctionFeb 5, 2024Break; Break

  IT WAS REPORTED THAT DURING A FOOT SURGERY IT WAS FOUND THAT THE THREADS OF THE ANCHOR WERE VERY THIN IN THE MIDDLE AND THEN TORE APART AT THIS POINT. 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 18643285 ↗
• MalfunctionJul 26, 2023Break; Break

  IT WAS REPORTED THAT DURING A BICEPS REFIXATION SURGERY THE TIP OF THE SCREWS BROKE OFF WHEN INSERTED. THE BROKEN PIECES WERE RETRIEVED FROM PATIENT. AS THERE WERE NO MORE SCREWS AVAILABLE THE SUTURES WERE TIGHTENED MANUALLY. 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 DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17395462 ↗
• MalfunctionJul 3, 2023Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER SURGERY WHEN SCREWING IN THE DEVICE WITHOUT MUCH FORCE, THE PIN BROKE OFF AT THE FRONT AND THE BLUE THREAD WAS CUT AND THE HEAD OF THE SCREW WAS DAMAGED. THEN THEY HAD TO REMOVE THE ANCHOR AND A NEW DEVICE WITH THE SAME PART NUMBER WAS USED TO FINISH THE SURGERY SUCCESSFULLY. 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: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17245839 ↗
• MalfunctionFeb 13, 2023Break

  IT WAS REPORTED THAT DURING A SURGERY AN ISSUE WITH THE REPORTED DEVICE OCCURRED. IT WAS FURTHER REPORTED THAT SOMETHING BROKE OFF INSIDE THE PATIENT. THE BROKEN PIECES REMAINED INSIDE THE PATIENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE ANYWAY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 16361801 ↗
• MalfunctionAug 1, 2022Break; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A RADIUS ARTHROSCOPY SURGERY WITH A BICEPS REINTEGRATION AT THE ELBOW THE SURGEON HAD A PROBLEM WITH AN ANCHOR THAT GOT STUCK IN THE CORTICAL BONE AND THE HANDLE TO INSERT IT BROKE. THE SURGEON HAD TO USE THE NEEDLE PROVIDED AND 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 15137652 ↗
• MalfunctionNov 8, 2021Break

  IT WAS REPORTED THAT DURING AN LATERAL ANKLE STABILITY SURGERY WHILE INSERTING THE ANCHOR, THE TIP BROKE OFF INSIDE THE ANCHOR. THE ANCHOR DID NOT HOLD AND THEREFORE THE SURGEON RETRIEVED THE ANCHOR AND SWITCHED TO A DIFFERENT THREAD TECHNIQUE REFIXATION WITHOUT AN ANCHOR.

  Patient problems: Insufficient Information

  MAUDE report 12770747 ↗
• InjuryMay 7, 2019Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT TWO AR-1915FT-1, SUTURE ANCHOR CORKSCREW FT, WERE USED FOR A BROSTÖM REPAIR IN THE FIBULA. PATIENT WAS A YOUNG MALE PROFESSIONAL FOOTBALL PLAYER WITH HARD BONE QUALITY. ALTHOUGH THE CORRECT STEPS WERE TAKEN - CORTEX PREDRILLING WITH K-WIRE WHICH IS INCLUDED IN THE CORKSCREW PACKAGE- BOTH CORKSCREWS BROKE OFF AT THE LEVEL OF THE SCREWDRIVER JUST ABOVE THE CORKSCREW. BROKEN PIECE REMAINS IN PATIENT. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE, PART NUMBER AR-1915SF-1. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE (B)(6), (B)(6) 2019: ONE SCREW IS STILL HALF WAY INSIDE PATIENT. SURGEON HAD NO MEANS OF TAKING IT OUT AGAIN. THE OTHER SCREW WAS COMPLETELY INSIDE THE BONE AND USABLE. THE BROKEN SCREW IS FIXED INSIDE THE FIBULA BONE AND STABLE. IT WILL NOT MOVE. A SECOND ANCHOR WAS USED TO COMPLETE THE BROSTÖM REPAIR.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8587845 ↗