Arthrex® AR-1318FTRecalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00888867008519), received between Apr 28, 2017 and Oct 22, 2025 — classified as 5 injuries, 25 malfunctions.

The most frequently reported specific device problem is “Break” (13 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 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 22, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA (B)(4) THAT AN AR-1318FT MICRO CORKSCREW SUTURE ANCHOR CAME LOOSE FROM THE STEM AND ROLLED AWAY DURING USE. NO PATIENT WAS AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23360375 ↗
• MalfunctionMay 29, 2025Failure to Advance; Failure to Advance

  ON 4/7/2025, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA EMAIL THAT AR-1318FT CORKSCREW FT SUTURES DID NOT SEAT ON BONE. THIS WAS DISCOVERED DURING A PROCEDURE. ADDITIONAL INFORMATION RECEIVED ON 5/6/2025: THIS WAS DISCOVERED DURING A TENORRHAPHY FOR LACERATION CENTRAL BAND IPP D2DRT PROCEDURE ON (B)(6) 2025. THE ANCHOR FAILED WHEN IT WAS ATTEMPTED TO BE FIXED IN THE PATIENT'S BONE. THE THREADS OF THE SCREWDRIVER DID NOT BITE INTO THE BONE. THE ANCHOR WAS REMOVED; HOWEVER, NOTHING BROKE INSIDE THE PATIENT. THE CASE WAS COMPLETED USING A NEW AR-1318FT CORKSCREW FT. THE CASE WAS DELAYED ABOUT FIVE MINUTES, BUT NO ADDITIONAL ANESTHESIA WAS NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22104837 ↗
• InjuryMay 1, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT REACTED HIGHLY ALLERGIC AFTER AN ARTHREX IMPLANT AR-1318FT WAS IMPLANTED.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 21945077 ↗
• MalfunctionJan 28, 2025Break; Break

  IT WAS REPORTED THAT DURING A DISTAL RADIAL FRACTURE THE SUTURE BECAME DETACHED FROM THE ANCHOR. 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. UPDATE DW 09-JAN-2025: FURTHER INFORMATION WAS PROVIDED THAT A PIECE BROKE OFF AND THE SUTURE THREAD SNAPPED INSIDE THE PATIENT BUT THE CUSTOMER WAS ABLE TO RETRIEVE EVERYTHING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21252649 ↗
• InjuryDec 6, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED BY THE CUSTOMER ON (B)(6) 2024 THAT THE CUSTOMER WAS IMPLANTED THE DEVICE AR-1318RT AND NOW HAS AN ALLERGIC REACTION. THIS WAS NOTICED AFTER THE SURGERY. THE MATERIAL SPECIFICATIONS WERE FORWARDED TO THE ATTENDING SURGEON. NO FURTHER INFORMATION RECEIVED. UPDATE DW 19-NOV-2024: FURTHER INFORMATION WAS PROVIDED THAT THE INITIAL SURGERY WAS PERFORMED ON (B)(6) 2024. IT WAS FURTHER REPORTED THAT THE ALLERGIC REACTION WAS NOTICED AT THE SCAR OF THE RIGHT THUMB WHERE THE DEVICE WAS IMPLANTED. NO FURTHER INFORMATION ARE CURRENTLY AVAILABLE.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 20863494 ↗
• MalfunctionNov 8, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ADDITIONAL INFORMATION RECEIVED ON 11/8/2024: THE DRIVER SPLIT JUST ABOVE THE ANCHOR. EVERYTHING WAS REMOVED FROM THE PATIENT. THE CASE WAS COMPLETED USING AN AR-1319 FT MINI CORKSCREW FT. THE CASE WAS DELAYED ABOUT TWO MINUTES WITHOUT ADDITIONAL ANESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20641991 ↗
• MalfunctionOct 3, 2024Break; Break

  ON (B)(6) 2024, IT WAS REPORTED BY A DISTRIBUTOR VIA (B)(4) THAT AN AR-1318FT SUTURE ANCHOR BROKE. THIS OCCURRED DURING A PROCEDURE AFTER PREDRILLING WITH THE LARGER OF THE 2 K-WIRES THE SURGEON WENT TO INSERT THE ANCHOR ON THE PATIENT WITH A DENSE CORTICAL BONE. THE SURGEON GOT THE ANCHOR ABOUT 70% INSERTED, AND THE SCREWDRIVER TIP COLLAPSED, THEY WITHDREW THE DRIVER, AND AS THE TIP HAD COLLAPSED, THE SLOT WHERE THE NEEDLES/STITCHES NORMALLY PASS WAS UNABLE TO BE DELIVERED THROUGH THE TIP AND IN DOING SO THE SHARPENED END OF THE DRIVER CUT THESE THREADS LEAVING ONLY THE ANCHOR PARTIALLY INSERTED. AFTER THE STITCH BECAME UNUSABLE, THE TEAM ATTEMPTED TO USE THE DRIVER TO REMOVE THE PARTIALLY INSERTED ANCHOR AND THE SCREWDRIVER TIP BROKE OFF. THE TEAM WAS ABLE TO RETRIEVE THE ANCHOR WITH A NEEDLE DRIVER AS IT WAS STILL PROUD. THEY THEN RE-DRILLED AND USED A SECOND ANCHOR, WHICH WORKED IN THE TYPICAL FASHION.

  Patient problems: Insufficient Information

  MAUDE report 20358130 ↗
• MalfunctionJul 10, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 7/3/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1318FT CORKSCREW FT ANCHOR WAS NOT ATTACHED TO THE INSERTER. THE SURGEON ATTEMPTED TO LOAD THE ANCHOR BACK ON, BUT IT BEGAN TO STRIP. ANOTHER AR-1318FT CORKSCREW FT WAS OPENED FROM THE SAME LOT NUMBER AND DID NOT HAVE THE ANCHOR ATTACHED TO THE INSERTER EITHER. THE SURGEON TRIED REATTACHING IT, BUT THE SUTURES PULLED OUT OF THE ANCHOR. THE CASE WAS COMPLETED WITH A COMBINATION OF SUTURES AND PRODUCTS FROM ANOTHER MANUFACTURER. THIS WAS DISCOVERED DURING A JOINT CAPSULE REPAIR PROCEDURE ON (B)(6) 2023.

  Patient problems: Insufficient Information

  MAUDE report 19714021 ↗
• MalfunctionJun 12, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ON 2/24/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1318FT CORKSCREW SUTURE ANCHOR WAS OFF THE INSERTER. THE SURGEON ATTEMPTED TO LOADED IT BACK ON AND WAS ABLE TO USE IT. TWO MORE CORKSCREW SUTURE ANCHOR WERE OPEN AND THE ANCHOR WAS OFF THE INSERTER. SURGEON LOADED THE ANCHOR BACK ON THE INSERTER AND THE SUTURES BROKE OFF DURING INSERTION. THE THIRD CORKSCREW SUTURE ANCHOR THAT HAD BEEN OPENED AND THE ANCHOR WAS ALSO OFF THE INSERTER, SURGEON DECIDED NOT TO USE IT, INSTEAD USED A PRODUCT FROM ANOTHER MANUFACTURER TO COMPLETE THE PROCEDURE. THIS WAS DISCOVERED DURING AN ANKLE ARTHROSCOPY, MEDIAL AND LATERAL LIGAMENTS REPAIR PROCEDURE (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19521756 ↗
• MalfunctionJun 4, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED DURING A HAND PROCEDURE, AS THE SURGEON INSERTED THE AR-1318FT SUTURE ANCHOR THE DRIVER CUT THE SUTURES ON THE ANCHOR OF THE IMPLANT. THE SURGEON USED A SECOND AR-1318FT SUTURE ANCHOR, AND THE SAME ISSUE OCCURRED. ALL BROKEN SUTURES AND THE ANCHORS WERE REMOVED. THE CASE WAS COMPLETED USING. PLEASE COMFIRM THE PART NUMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19463971 ↗
• MalfunctionJun 4, 2024Break; Break

  ON 05/08/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT (3) AR-1317FT NANO CORKSCREW AND AN AR-1318FT MICRO CORKSCREWS IMPLANT HEAD BROKE DURING INSERTION. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. CASE COMPLETED DRILLING BONE TUNNELS TO SECURE LUNATE. DELAY IN CASE 30 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19463611 ↗
• MalfunctionJun 1, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A FOOT SURGERY THE SUTURE OF THE DEVICE JUMPED OUT OF THE HOLDER BECAUSE OF MISSING BACKUP AND THE ANCHOR FELL OFF AND WAS NO LONGER FIXABLE. NO PART OF THE DEVICE BROKE OFF. 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 19442043 ↗
• MalfunctionMay 25, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY WHEN THEY OPENED THE PACKAGING THEY REALIZED THAT THE TIP ANCHOR WAS DISASSEMBLED. 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 19398297 ↗
• MalfunctionMay 24, 2024Break; Break

  ON 3/21/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT (2) AR-1318FT CORKSCREW SUTURE ANCHORS BROKE IN HALF INSIDE THE PATIENT'S JOINT. ALL BROKEN FRAGMENTS WERE RETRIEVED AND TWO MORE AR-1318FT CORKSCREW SUTURE ANCHORS WERE OPENED; HOWEVER, BOTH OF THE ANCHORS FELL OFF THE INSERTER AND COULD NOT BE RELOADED BACK ON THE INSERTER SHAFT. SURGEON OPENED A FIFTH AR-1318FT CORKSCREW SUTURE ANCHOR TO COMPLETE THE CASE. THIS WAS DISCOVERED DURING A FLEXOR TENDON REPAIR ON (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19392223 ↗
• MalfunctionMay 10, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING WRIST/HAND PROCEDURE, WHEN THE SURGEON INSERTED THE ANCHOR INTO THE PATIENT'S FIRST METACARPAL, THE SUTURE TORE COMPLETELY, FREEING THE CORKSCREW ANCHOR FROM THE INSERTER. THE ANCHOR WAS ONLY PARTIALLY SCREWED IN SO THE SURGEON WAS ABLE TO REMOVE THE ANCHOR FROM BONE, AND A NEW AR-1318FT WAS USED TO COMPLETE THE CASE.

  Patient problems: Insufficient Information

  MAUDE report 19285438 ↗
• MalfunctionMay 2, 2024Defective Device; Defective Device

  ON 6/6/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE VIA THAT (2) AR-1318FT FT MICRO CORKSCREW ANCHORS WERE OFF THE INSERTER. THIS WAS DISCOVERED BEFORE OPENING THE SEALED PACKAGED FOR A THUMB PROCEUDRE ON (B)(6)2022. ANOTHER ONE WAS OPENED TO COMPLETE THE CASE WITHOUT FURTHER ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19231570 ↗
• MalfunctionApr 29, 2024Defective Device; Defective Device

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-1318FT SUTURE ANCHOR HAD AN ISSUE. DURING A HAND AND WRIST PROCEDURE FOR A MEDI CARPAL FRACTURE ON (B)(6) 2022, WHEN THE SCRUB LOOKED AT THE IMPLANT AFTER HAVING OPENED THE PACKAGE ON THE BACK TABLE, THE ANCHOR TIP HAD COME OUT OF THE DRIVER AND COULD NOT BE LOADED BACK ONTO THE DRIVER, THE DEVICE WAS DAMAGED OUT-OF-BOX. NOTHING BROKE OFF INSIDE THE PATIENT, IT ALL OCCURRED ON THE BACK TABLE. THEY OPENED A NEW AR-1318FT SUTURE ANCHOR WITH THE SAME LOT NUMBER TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19201710 ↗
• MalfunctionFeb 19, 2024Break; Break

  IT WAS REPORTED THAT DURING A FIXATION SURGERY WITH CORKSCREW ANCHOR THE ANCHOR BROKE OFF INSIDE THE PATIENT. THE BROKEN PIECE WAS RETRIEVED FROM PATIENT. 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 18731482 ↗
• MalfunctionAug 4, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1318FT CORKSCREW FT ANCHOR WAS DISLODGED FROM THE INSERTER AND COULD NOT BE PUT BACK ON. THIS WAS DISCOVERED DURING A JERSEY FINGER REPAIR PROCEDURE ON (B)(6) 2023. THE CASE WAS COMPLETED USING (2) NANO CORKSCREWS. ADDITIONAL INFORMATION PROVIDED (B)(6) 2023: BEFORE EVEN OPENING THE PACKAGE, THE ANCHOR DETACHED FROM THE INSERTER. THE DEVICE WAS NOT USED DURING THE PROCEDURE. THE CASE WAS COMPLETED BY USING A NEW AR-1317FT.

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

  MAUDE report 17461817 ↗
• MalfunctionAug 2, 2023Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  ON (B)(6)/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1318FT CORKSCREW FT ANCHOR WAS NOT ATTACHED TO THE INSERTER. THE SURGEON ATTEMPTED TO LOAD THE ANCHOR BACK ON, BUT IT BEGAN TO STRIP. ANOTHER AR-1318FT CORKSCREW FT WAS OPENED FROM THE SAME LOT NUMBER AND DID NOT HAVE THE ANCHOR ATTACHED TO THE INSERTER EITHER. THE SURGEON TRIED REATTACHING IT, BUT THE SUTURES PULLED OUT OF THE ANCHOR. THE CASE WAS COMPLETED WITH A COMBINATION OF SUTURES AND PRODUCTS FROM ANOTHER MANUFACTURER. THIS WAS DISCOVERED DURING A JOINT CAPSULE REPAIR PROCEDURE ON (B)(6)2023.

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

  MAUDE report 17442574 ↗
• InjuryJun 22, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2023, IT WAS REPORTED BY A PATIENT VIA PHONE THAT SHE IS EXPERIENCING A REACTION TO AN AR-1318FT SUTURE ANCHOR. THE ANCHOR WAS IMPLANTED IN 2018 AT MAYO CLINIC. THE PATIENT HAS EXPERIENCED PAIN ON A REGULAR BASIS, AND EXTREME SENSITIVITY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 17180840 ↗
• MalfunctionMar 27, 2023Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-1318FT CORKSCREW FT BROKE DURING INSERTION. THE BROKEN FRAGMENTS COULD NOT BE RETRIEVED. THE CASE WAS COMPLETED USING ANOTHER AR-1319FT MINI CORKSCREW FT IN A NEW BONE SOCKET. THIS WAS DISCOVERED DURING A PROCEDURE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body In Patient

  MAUDE report 16618091 ↗
• MalfunctionDec 7, 2022Break

  IT WAS REPORTED THAT DURING A SURGERY THE FIBERWIRE SNAPPED WHEN PUTTING THE ANCHOR UNDER TENSION. THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT. THERE WAS NO HARM FOR THE 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; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15931166 ↗
• MalfunctionJul 5, 2022Break; Material Frayed; Defective Device

  ON 6/14/2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN (B)(4) SUTURE ANCHOR BROKE DURING A ULNAR SHEATH REPAIR. THE IMPLANT BROKE DURING INSERTION WHERE THE DRIVER MEETS THE ANCHOR AND THE SUTURES WERE FRAYED. ALL WAS RETRIEVED. A SECOND SUTURE ANCHOR WAS USED AND THAT ONE ALSO FRAYED THE SUTURES DURING INSERTION. ALL DEBRIS WAS RETRIEVED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION PROVIDED. ADDITIONAL INFORMATION: THEY WERE UNABLE TO REMOVE THE SECOND DEFECTIVE ANCHOR FROM THE PATIENT. IT IS COUNTERSUNK IN THE BONE BUT WILL NOT CAUSE IRRITATION. TO COMPLETE THE CASE A LARGER ANCHOR WAS USED (MICRO CORKSCREW) IN THE SAME DRILL HOLE AS AN ALTERNATIVE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 14914522 ↗
• MalfunctionApr 11, 2022Break; Activation, Positioning or Separation Problem

  ON 3/21/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT (2) AR-1318FT CORKSCREW SUTURE ANCHORS BROKE IN HALF INSIDE THE PATIENT'S JOINT. ALL BROKEN FRAGMENTS WERE RETRIEVED AND TWO MORE AR-1318FT CORKSCREW SUTURE ANCHORS WERE OPENED; HOWEVER, BOTH OF THE ANCHORS FELL OFF THE INSERTER AND COULD NOT BE RELOADED BACK ON THE INSERTER SHAFT. SURGEON OPENED A FIFTH AR-1318FT CORKSCREW SUTURE ANCHOR TO COMPLETE THE CASE. THIS WAS DISCOVERED DURING A FLEXOR TENDON REPAIR ON (B)(6) 2022.

  Patient problems: Insufficient Information

  MAUDE report 14074689 ↗