Arthrex® AR-1920SFRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00888867022829), received between Jan 11, 2022 and Aug 14, 2025 — classified as 1 injury, 14 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. 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 14, 2025Material Fragmentation; Difficult to Insert; Material Fragmentation; Difficult to Insert

  ON 07/29/2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-1920SF SUTURE ANCHOR WAS USED TO REPAIR THE ROTATOR CUFF. THE CORRESPONDING PUNCH WAS USED TO MAKE THE ANCHOR ENTRY. WHEN BEGINNING TO INSERT IT, IT ADVANCED APPROXIMATELY HALFWAY AND BEGAN TO PASS THE ANCHOR SHAFT, DAMAGING IT AND LEAVING RESIDUE. THEREFORE, THE CORRESPONDING MANEUVERS HAD TO BE PERFORMED TO REMOVE IT, AS IT HAD BECOME VERY PROTRUDING.

  Patient problems: Insufficient Information

  MAUDE report 22803506 ↗
• MalfunctionJul 25, 2025Break; Break

  ON 3RD JULY 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA EMAIL THAT FOR AN AR-1920SF, SUTURE ANCHOR, CORKSCREW® 5 MM X 15.5 MM WITH #2 FIBERWIRE® AND #2 TIGER WIRE®, ITS ANCHOR BROKE DURING INSERTION. THIS WAS DETECTED DURING A ROTATOR CUFF REPAIR SURGERY ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER BRAND PRODUCTS. THERE WAS NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22608805 ↗
• MalfunctionDec 30, 2024Material Deformation; Material Deformation

  ON 4TH DECEMBER 2024, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-1920SF CORKSCREW ANCHOR WAS DEFORMED DURING IMPLANTATION. THIS WAS DETECTED DURING A RIGHT KNEE ARTHROSCOPIC ANTERIOR AND POSTERIOR CRUCIATE LIGAMENT RECONSTRUCTION AND INTERNAL COLLATERAL LIGAMENT RECONSTRUCTION SURGERY ON (B)(6) 2024. AR-1927PB AND AR-2324PTB WAS USED TO PREPARE BONE SOCKET. THE ANCHOR WAS DEFORMED, RESULTING IN IMPLANTATION FAILURE. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED, BY USING ANOTHER NEW AR-1920SF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21036234 ↗
• MalfunctionOct 2, 2024Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY WHEN PULLING BACK THE GUIDE SLEEVE OF THE ANCHOR, PARTS OF THE SLEEVE AND THE ANCHOR BROKE OFF. ALL METAL PARTS THAT BROKE OFF COULD BE REMOVED AND THE ANCHOR REMAINS FUNCTIONAL IN THE BONE. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20353424 ↗
• MalfunctionJun 4, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A ROTATOR CUFF PROCEDURE, WHEN THE SURGEON WAS PLACING THE ANCHOR, THE AR-1920SF ROLLED IN THE UNION OF THE ANCHOR AND THE STEM INSERT, WHICH COULD NOT BE USED, AND WAS REMOVED FROM THE PATIENT. A SECOND ANCHOR WAS PLACED WITHOUT ANY ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19464182 ↗
• MalfunctionJun 3, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A ROTATOR CUFF PROCEDURE, WHEN THE SURGEON WAS IMPLANTING THE AR-1920SF, THE ANCHOR ROLLED AND WAS REMOVED FROM THE PATIENT. THE CASE WAS COMPLETED BY USING A NEW AR-1920SF. IMAGES ATTACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19449361 ↗
• MalfunctionMay 24, 2024Material Twisted/Bent; Material Twisted/Bent

  ON 3/21/2022, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-1920SF CORKSCREW SUTURE ANCHOR TIP WAS FOUND TO BE BENT. SURGEON OPENED ANOTHER AR-1920SF CORKSCREW SUTURE ANCHOR AND CASE WAS COMPLETED WITHOUT FURTHER ISSUES. THIS WAS DISCOVERED UPON OPENING PACKAGE DURING PROCEDURE ON (B)(6) 2022. ADDITIONAL INFORMATION RECEIVED ON 3/22/2022: THIS WAS DISCOVERED DURING A KNEE JOINT PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19392184 ↗
• MalfunctionMay 24, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A DISTAL BICEPS TENODESIS SURGERY THE DEVICE COULD NOT BE SCREWED INTO THE DRILL HOLE, AS THE BODY OF THE ANCHOR WAS DAMAGED / BENT DURING INSERTION. 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. UPDATE AVOE 28-MAR-2022: IT WAS CONFIRMED THAT 2X AR-1920SF (LOT 12990795) ARE AFFECTED IN THIS CASE AND THE DEVICE AR-1915SF WITH THE LOT 12943197 WAS FALSELY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19392033 ↗
• MalfunctionMay 3, 2024Break; Break

  ON 04/11/2024, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-1920SF CORKSCREW ANCHOR BROKE DURING INSERTION. ALL THE BROKEN FRAGMENTS WERE REMOVED SUCCESSFULLY. THE CASE WAS COMPLETED USING ANOTHER AR-1920SF CORKSCREW. THIS WAS DISCOVERED DURING A COLLATERAL LIGAMENT INJURY REPAIR PROCEDURE ON (B)(6) 2024. THE PATIENT SUFFERED NO NEGATIVE EFFECTS. ADDITIONAL INFORMATION RECEIVED ON 4/23/2024: THE CASE WAS DELAYED TEN MINUTES; ADDITIONAL ANESTHESIA WAS NOT NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19239913 ↗
• MalfunctionFeb 19, 2024Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT DURING A ROTATOR CUFF SURGERY THE HANDLE HAS COME LOOSE FROM THE SHAFT SO THE SCREW COULD NOT BE SCREWED IN. 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 18731502 ↗
• MalfunctionJan 22, 2024Break; Break

  ON 1/2/2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT AN AR-1920SF CORKSCREW ANCHOR BROKE DURING INSERTION. THE BROKEN FRAGMENTS WERE REMOVED AND THE CASE WAS COMPLETED USING ANOTHER AR-1920SF CORKSCREW ANCHOR. THIS WAS DISCOVERED DURING AN RCR PROCEDURE ON (B)(6) 2023. THE PATIENT SUFFERED NO NEGATIVE EFFECTS ON OR AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18553165 ↗
• MalfunctionDec 27, 2023Break; Break

  ON 12/1/2023, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-1920SF. SUTURE ANCHOR BROKE. WHEN THE ANCHOR WAS INSERTED INTO THE PATIENT, THE KEY BROKE OFF AND THE TIP BROKE OFF. THE BROKEN ANCHOR WAS REMOVED WITH AN OSTEOTOMY AND A HAMMER. A NEW ANCHOR WAS USED TO FINISH THE PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 18404427 ↗
• MalfunctionDec 15, 2023Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-1920SF SUTURE ANCHORS TIP BROKE. THIS OCCURRED DURING A CASE WHERE THE PATIENT HAD A HARD BONE THAT WAS DRILLED WITH A PRIMER AND THEN THE ANCHOR BROKE. THE BROKEN ANCHOR WAS REMOVED, AND THE SURGICAL TIME WAS INCREASED.

  Patient problems: Insufficient Information

  MAUDE report 18340773 ↗
• MalfunctionDec 14, 2023Break; Break

  ON 11/06/2023, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT AN AR-1920SF CORKSCREW ANCHOR BROKE. THIS WAS DISCOVERED DURING A RIGHT KNEE ARTHROSCOPY AND CLEAN-UP PROCEDURE ON 4//11/2023. THE CASE WAS COMPLETED BY REMOVING ALL BROKEN FRAGMENTS AND USING ANOTHER AR-1920SF CORKSCREW. ADDITIONAL INFORMATION WAS RECEIVED ON 11/20/2023: THE CASE WAS DELAYED FOR FIFTEEN MINUTES, BUT NO ADDITIONAL ANESTHESIA WAS NEEDED. THE PATIENT SUFFERED NO NEGATIVE EFFECTS ON OR AFTER THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18331152 ↗
• InjuryJan 11, 2022Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021, IT WAS REPORTED BY A ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-1920SF CORKSCREW SUTURE ANCHOR WAS SUCCESSFULLY IMPLANTED IN PATIENT DURING A PATELLAR LIGAMENT REPAIR ON (B)(6) 2021. LATER, PATIENT DISCOVERED SECRETION FROM INCISION WHICH WAS TREATED WITH ANTIBIOTICS. IT HAS ALSO BEING REPORTED THAT PATIENT IS DOING WELL AFTER ANTIBIOTIC TREATMENTS.

  Patient problems: Fluid Discharge

  MAUDE report 13225221 ↗